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13/03/2019

Santa Clara, Calif. – March 11, 2019 – ShockWave Medical, Inc. (“ShockWave”) (Nasdaq: SWAV), today announced the closing of its initial public offering of 6,555,000 shares of its common stock at an initial public offering price of $17.00 per share, including 855,000 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares. Including the option exercise, the aggregate gross proceeds to ShockWave from the offering, before deducting underwriting discounts and commissions and other offering expenses, were approximately $111.4 million. ShockWave’s common stock is listed on the Nasdaq Global Select Market under the ticker symbol “SWAV”.

Morgan Stanley and BofA Merrill Lynch acted as joint lead book-running managers for the offering. Wells Fargo Securities and Canaccord Genuity acted as co-managers for the offering. Parella Weinberg Partners acted as independent capital markets advisor to ShockWave for the offering.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on March 6, 2019. The offering was made only by means of a prospectus. A copy of the final prospectus may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; or BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255‐0001, Attention: Prospectus Department, or by email at dg.prospectus_requests@baml.com.

In addition to the shares sold in the initial public offering, ShockWave also announced today the closing of its offering of an additional 588,235 shares of its common stock in a concurrent private placement at $17.00 per share to one of its existing investors, Abiomed, Inc., that exercised its option to purchase shares of common stock. This sale resulted in additional gross proceeds to ShockWave of approximately $10.0 million. The sale of these shares was not registered under the Securities Act of 1933, as amended.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

About ShockWave Medical, Inc.
ShockWave Medical is a medical device company focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. ShockWave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Caution Regarding Forward-Looking Statements
This press release may contain forward-looking statements regarding ShockWave’s current expectations. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements.

These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, those described more fully in the section captioned “Risk Factors” in the final prospectus related to the public offering filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and ShockWave undertakes no duty to update such information except as required under applicable law.

17/01/2019

PARIS, January 17, 2019 – HighLife SAS, a medtech company focused on the development of a unique transcatheter mitral valve replacement (« TMVR ») system to treat patients suffering from mitral regurgitation, announced today it had closed a € 32 million round of equity financing.

Proceeds from the financing will be used to complete the development of the company’s transcatheter transseptal mitral valve implantation program, which includes regulatory approval trials in Europe to obtain the CE mark and a first clinical trial in the U.S. via an Early Feasibility Study (EFS).

The Series B round was co-led by U.S. Venture Partners (« USVP ») and Andera Partners, with Sectoral Asset Management and Jose Calle Gordo, Chairman of the company, joining the round. Sofinnova Partners, which led the Series A round, continues to support the company and participated in this latest round of financing. Bryan Garnier & Co (Paris) acted as private placement agent for this financing.

« I am very pleased to announce the closing of the Series B financing round, which is essential to funding the development program of the company. The funds will support our mid-term strategy with a pivotal trial in Europe and a clinical trial in the U.S. » said Georg Börtlein, HighLife’s CEO and Founder. « We remain committed to bringing the best treatment option for the broadest patient population to market. Over the long term, we want to address any limitation that the field of TMVR faces and we will continue working towards that goal. »

Based in Paris, France, HighLife was founded in 2010 by Mr. Börtlein. Following Sofinnova Partners’ investment in HighLife in 2017, the venture capital firm’s Managing Partner Antoine Papiernik joined HighLife’s Board. In December 2017, Mr. Calle Gordo, most recently CEO of Biosensors and a longtime specialist in cardiovascular devices, was named chairman. In May 2018, Dr. Martin Rothman, interventional cardiologist and retired Chief Medical Officer of Medtronic, joined as CMO and member of the board. USVP will be represented on the board by Casey Tansey, while Andera Partners will be represented by Olivier Litzka.

« HighLife’s creative approach has already generated convincing data in this competitive field of mitral valve replacement. I am confident that the experienced management team will bring this technology to the level where it becomes an undisputed treatment option for mitral valve regurgitation patients, » said Mr. Tansey, General Partner at USVP.

« With our already solid experience in the structural heart field, we are very happy to contribute to and support HighLife. The exceptional level of collective experience brought together with the existing team and the new investors is a favorable omen for HighLife’s success » said Mr. Litzka, partner at Andera Partners.

« Sofinnova is thrilled to continue supporting HighLife through this new financing, which gives the company the means to demonstrate the clinical importance of its transseptal product, » said Mr. Papiernik.

« We are very proud that we could attract highly experienced and internationally recognized investors like USVP, Andera and Sectoral Asset Management. This speaks for the credibility of our development program, management team and the potential of our technology to serve a major yet underserved clinical need, » said Mr Calle Gordo.

HighLife’s technology targets optimal treatment outcomes as it can be delivered transseptally via the femoral vein in a reversible manner, and self-locates inside the native annulus. The transseptal route is the preferred route for both interventionists and patients, as it avoids any surgery.

About HighLife
HighLife SAS was established in 2010 and is headquartered in Paris, France, with offices in Irvine (California). It is focused on the development of a novel transcatheter replacement system for treating mitral regurgitation. The technology aims at a beating heart procedure reducing trauma to the patients.
Caution: The HighLife Transcatheter Mitral Valve is an investigational device and not available for sale.

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together a team of professionals from all over Europe, the US and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners seeks to invest as a lead or cornerstone investor in seed, start-ups, corporate spin-offs and late stage companies. It has backed nearly 500 companies over more than 45 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.9 billion under management.
For more information: www.sofinnova.fr.

About USVP
U.S. Venture Partners (USVP) is a leading Silicon Valley venture capital firm, partnering with entrepreneurs to transform their ideas into world-changing companies. USVP has invested in over 400 companies spanning three decades, including: Box, Castlight Health, Check Point Software, Concur, GoPro, Guidewire Software, HotelTonight, Imperva, InsideSales.com, Inspire Medical, Intersect ENT, Omada Health, OncoMed, Prevoty, SanDisk, Sun Microsystems, Trunk Club, Trusteer, Yammer, and Zerto. USVP focuses on early-stage start-ups that transform cybersecurity, enterprise software, consumer mobile and e-commerce, and healthcare. The USVP team consists of former entrepreneurs, technologists, corporate executives, and financial professionals who assist with strategy, scaling, team building, product development, and business development. USVP is based in Menlo Park, California. More information can be found at www.usvp.com.

About Andera Partners
Andera Partners (previously Edmond de Rothschild Investment Partners) is a leading investor in minority investments into privately owned companies. The Management Company employs 56 people and has more than €2 billion under management. Its Life Sciences team of 12 professionals brings together deep experience both in the Life Science industry and in private equity and venture capital. The team has raised more than €800 million through its BioDiscovery franchise and is currently investing out of its €345 million BioDiscovery 5 fund, both in biotech and medtech, and all over Europe and the US. For more information, please visit www.anderapartners.com.

About Sectoral Asset Management
Sectoral Asset Management is an established global healthcare specialist. Sectoral leverages its expertise and capabilities to capture significant value creation across both public and private companies. More information about the firm and its track record is available at www.sectoral.com.

For more information, please contact:

HIGHLIFE Contact International Contact France
www.highlifemedical.com
Marion Janic Anne Rein
Tel : +33 (0)1 72 32 21 15 Tel: +1 (212) 223 4017 Tel: +33 6 03 35 92 05
info@highlifemed.com
mjanic@rooneyco.com
anne.rein@strategiesimage.com

17/01/2019

Serial biotech entrepreneur joins leading small molecule tau modulation company

Lausanne, SWITZERLAND and Cambridge, MA, USA, January 17, 2019 – Asceneuron, an emerging leader in the development of orally bioavailable modulators of tau pathology for the treatment of neurodegenerative diseases, today announces the appointment of Peter Van Vlasselaer as Chair of the Board of Directors.

Peter Van Vlasselaer, PhD has over 20 years executive and entrepreneurial experience in the biotech industry. He was most recently the Founder, President and Chief Executive Officer of ARMO Biosciences, Inc. which shortly after its public offering (Nasdaq: ARMO) was acquired by Eli Lilly. Prior to this, he was President and Chief Executive Officer of iPierian (acquired by BMS), ARRESTO (acquired by Gilead) and AVIDIA (acquired by AMGEN). In addition to founding ARMO, Dr. Van Vlasselaer was the founder of ARRESTO, co-founder of TrueNorth (acquired by Bioverativ) and was a member of the start-up teams of InterMune (ITMN) and Dendreon (DNDN). He currently serves on the boards of BLADE Therapeutics, Comet Therapeutics and RGENIX. Dr. Van Vlasselaer has a degree in Zoology and a PhD in Immunology from the Catholic University of Leuven, Belgium. He was a Post-Doctoral Fellow in the Division of Immunology and Rheumatology at Stanford University Medical School and DNAX Research Institute. Dr. Van Vlasselaer has authored several peer reviewed scientific publications and book chapters and he is an inventor on multiple patents.

Dirk Beher, Chief Executive Officer and Founder of Asceneuron, commented:
“We are delighted to welcome Peter Van Vlasselaer to the Board. His extensive experience in all aspects of biotechnology, drug and corporate development will be invaluable as the Company progresses its orally-bioavailable tau modifiers through clinical development. With Peter’s addition to the board, our expanded US presence, and commitment to tau, Asceneuron is well positioned to revolutionize the treatment of neurodegenerative diseases.”

Peter Van Vlasselaer, new Chairman of Asceneuron, added:
“There is a strong industry and scientific interest in tau approaches to Alzheimer’s disease and orphan tauopathies such as progressive supranuclear palsy (PSP). I believe Asceneuron’s technology represents a significant opportunity in the next generation of drugs that could potentially transform the treatment of PSP and other tau-related neurodegenerative diseases. These disorders have devastating outcomes for patients and their families. I look forward to maximising the potential of these innovative new treatments and support the Company through this important phase of growth.”

Asceneuron’s lead program ASN120290 is a small molecule inhibitor of the enzyme O-GlcNAcase. Based on its unique mechanism of action, ASN120290 has the potential to become a first in class treatment for progressive supranuclear palsy (PSP) and other tau-related dementias.
The company recently announced the appointment of CNS specialist Dr Thomas C. Wessel as Chief Medical Officer. A clinical trial is ongoing with ASN120290 to quantify target engagement in the human brain using positron emission tomography (PET) the results of which will guide dose selection for an efficacy trial in PSP planned for later this year.

For further information, please contact:
Asceneuron
Dirk Beher, CEO
Email: asce-contact@asceneuron.com

Optimum Strategic Communications
Mary Clark, Supriya Mathur
Tel: +44 203 922 0891
Email: asceneuron@optimumcomms.com

About Asceneuron
Asceneuron is an emerging, clinical stage biotech company excelling in the development of orally bioavailable therapeutics for debilitating neurodegenerative disorders with high unmet medical need, such as orphan tauopathies, Alzheimer’s and Parkinson’s diseases. The lead program ASN120290, an O-GlcNAcase inhibitor, is being developed for the orphan tauopathy progressive supranuclear palsy (PSP). Asceneuron has completed a randomized, double-blind, placebo-controlled phase I study to assess the safety and tolerability of single and multiple doses of orally administered ASN120290. Asceneuron is a privately held company financed by a strong syndicate of investors consisting of Sofinnova Partners, M Ventures, SR One, Johnson & Johnson Innovation – JJDC, Inc. (JJDC) and Kurma Partners. For more information, please visit www.asceneuron.com.

About ASN120290
Asceneuron’s lead program ASN120290, an O-GlcNAcase inhibitor, is being developed for the orphan tauopathy progressive supranuclear palsy (PSP) and was recently granted Orphan Drug Designation by the US FDA for the treatment of PSP. ASN120290 has recently completed a randomized, double-blind, placebo-controlled phase I study to assess its safety and tolerability of single and multiple doses in healthy young and elderly volunteers. Data from that study were presented at the Alzheimer’s Association International Conference (AAIC) in Chicago July 22-26, 2018.

About Progressive Supranuclear Palsy (PSP)
PSP, also known as Steele-Richardson-Olszewski syndrome, is a rapidly progressing neurodegenerative disorder. PSP is often misdiagnosed because it is relatively rare and certain symptoms are similar to Parkinson’s disease. However, PSP is much more common than previously believed. Its prevalence is about three to six people per 100,000 individuals. Symptoms generally appear in the 60s-70s but can affect people from the age of 40 onwards. There are currently no treatments available to cure this disease.

11/01/2019

• L’implant est bien toléré et préserve l’acuité visuelle périphérique résiduelle.
• Tous les patients perçoivent de la lumière au centre de leur champ visuel.
• La majorité des patients identifie des signaux complexes, des lettres ou des séquences de lettres.
• Ces résultats intérimaires positifs permettent de préparer l’étude pivot européenne multicentrique.

Paris, 8 janvier 2019 – 7h00 CET – Pixium Vision (FR0011950641 – PIX), société bioélectronique qui développe des systèmes de vision bionique innovants pour permettre aux patients ayant perdu la vue de vivre de façon plus autonome, annonce que son dispositif sous-rétinien PRIMA a atteint les objectifs de l’étude de faisabilité1 après 6 mois de suivi et de rééducation de patients atteints de la forme sèche de Dégénérescence Maculaire liée à l’Age (DMLA).
Khalid Ishaque, Directeur Général de Pixium Vision, commente : « Nous sommes particulièrement satisfaits du remarquable succès obtenu avec le dispositif PRIMA chez les patients atteints de la forme sèche de la DMLA. Ces résultats dépassent nos attentes. Ainsi, chez des patients ayant totalement perdu leur vision centrale, PRIMA permet à la majorité d’entre eux de commencer à identifier correctement des signaux et des lettres. Nous espérons que ces premiers résultats très positifs attirent les candidats éligibles pour l’étude de faisabilité PRIMA2 en cours de recrutement aux Etats-Unis. Après avoir franchi avec succès cette étape majeure, nous préparons dès maintenant l’étude clinique pivot européenne, un pas de plus vers le marquage CE de PRIMA. »
Les résultats cliniques intérimaires à 6 mois de PRIMA, micropuce photovoltaïque sans fil, chez les patients atteints de la forme sèche de DMLA, montrent :
• PRIMA peut être implanté de manière sûre sous la macula atrophique, et préserve l’acuité visuelle périphérique résiduelle, mesurée dans des conditions normalisées3.
• Restitution d’une perception lumineuse, chez tous les patients, dans la zone centrale de la rétine qui avait perdu toute activité visuelle, objectivée par des tests cliniques normalisés4.
1 Study of Compensation for Blindness with the PRIMA System in Patients with Dry Age-Related Macular Degeneration (PRIMA FS) https://www.clinicaltrials.gov/ct2/show/NCT03333954
2 Feasibility Study of Compensation for Blindness with the PRIMA System in Patients with Atrophic Dry Age Related Macular Degeneration (PRIMA-FS-US) https://clinicaltrials.gov/ct2/show/NCT03392324
3 Mesuré par le test ETDRS
4 Mesuré par les tests de micropérimétrie et de mesure du champ visuel Octopus

• Une bonne tolérance de l’implant sans effets indésirables sévères liés à l’implant. L’implant ne bouge pas après cicatrisation naturelle de la rétine, et reste stable chez tous les patients.
• L’identification de signaux, de chiffres et de lettres chez la majorité des patients. La rapidité et la justesse des identifications s’améliorent constamment au cours de la phase de rééducation.
• La mesure de l’acuité visuelle prosthétique centrale 5 jusqu’à 20/460 (LogMAR 1,37), chez des patients n’ayant plus aucune perception visuelle centrale naturelle. Les résultats d’acuité visuelle obtenus sont les meilleurs jamais atteints au regard des résultats publiés avec les technologies actuelles de vision prothétique.
Pixium Vision prépare dès à présent une importante étude pivot européenne multicentrique, phase nécessaire à l’obtention du marquage CE.
Prochain évènement : 8 février 2019 – Publication des résultats annuels 2018
5 Sur la base du test d’acuité visuelle LandoltC

Contacts
Pixium Vision
Didier Laurens, CFO
investors@pixium-vision.com
+33 1 76 21 47 68

Relations Presse
Newcap Media
Annie-Florence Loyer – afloyer@newcap.fr
+33 1 44 71 00 12 / +33 6 88 20 35 59
Léa Jacquin – ljacquin@newcap.fr
+33 1 44 71 94 94

Relations Investisseurs USA
ICR
David Clair
david.clair@icrinc.com
+1 646 277 12 66

À PROPOS DE PRIMA
PRIMA est un implant miniature de nouvelle génération totalement sans fil ni connexion. Micro-puce photovoltaïque de 2 millimètres et 30 microns d’épaisseur, PRIMA est constitué de 378 électrodes. Implanté sous la rétine par chirurgie peu invasive, PRIMA convertit le signal infra-rouge, reçu d’un projecteur miniaturisé fixé sur une paire de lunette munie d’une mini-camera, en un signal électrique transmis au cerveau par l’intermédiaire du nerf optique. PRIMA est destiné au traitement des dystrophies rétiniennes. De par sa taille, conçue pour préserver la vision résiduelle des patients, PRIMA est particulièrement adapté à la prise en charge de la forme sèche de DMLA, la forme la plus fréquente de cette pathologie. PRIMA est également susceptible d’être développé dans la rétinite pigmentaire.

A PROPOS DE LA DEGENERESCENCE MACULAIRE LIEE A L’AGE (DMLA)
La dégénérescence maculaire liée à l’âge est la première cause de perte sévère de la vision et de cécité chez les personnes de plus de 65 ans en Europe et aux Etats-Unis. Selon les estimations1, la DMLA affecte environ 196 millions de personnes dans le monde, un chiffre en constante augmentation du fait du vieillissement de la population. Près de 1 000 nouveaux cas sont diagnostiqués quotidiennement en Europe et aux Etats-Unis. Il existe deux formes de DMLA : une forme humide pour laquelle les traitements de type anti-VEGF permettent de ralentir la progression de la maladie ; et une forme sèche, plus fréquente, pour laquelle il n’existe actuellement aucun traitement disponible. Plus de 5 millions de personnes souffrent d’une forme avancée de DMLA sèche, ou Atrophie Géographique (GA). Les personnes atteintes de cette pathologie rétinienne perdent graduellement leur vision centrale (responsable de la vision précise et détaillée comme la lecture et la reconnaissance des visages) du fait de la mort des photorécepteurs.

À PROPOS DE PIXIUM VISION
La mission de Pixium Vision est de créer un monde de vision bionique pour permettre à ceux qui ont perdu la vue de récupérer en partie leur perception visuelle et gagner en autonomie. Les systèmes de vision bionique de Pixium Vision sont associés à une intervention chirurgicale et à une période de rééducation.
Pixium Vision conduit des études cliniques de faisabilité avec PRIMA, son implant sous-rétinien miniaturisé et sans fil, chez des patients qui ont perdu la vue par dégénérescence rétinienne liée à la forme sèche de la Dégénérescence Maculaire Liée à l’Age (DMLA). Pixium Vision travaille en étroite collaboration avec des partenaires académiques de renommée mondiale tels que, l’Université Stanford en Californie, l’Institut de la Vision à Paris, le Moorfields Eye Hospital de Londres et l’Institute of Ocular Microsurgery (IMO) de Barcelone et l’UPMC de Pittsburgh (USA). La société est certifiée EN ISO 13485. Pixium Vision a reçu la qualification « Entreprise Innovante » par Bpifrance
1 Wong, W. L., Su, X., Li, X., Cheung, C. M. G., Klein, R., Cheng, C. Y., & Wong, T. Y. (2014). Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. The Lancet Global Health, 2(2), e106-e116 (https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(13)70145-1/fulltext)

Pour plus d’informations : http://www.pixium-vision.com/fr
Suivez-nous sur @PixiumVision; www.facebook.com/pixiumvision
www.linkedin.com/company/pixium-vision

Avertissement :
Le présent communiqué contient de manière implicite ou expresse certaines déclarations prospectives relatives à Pixium Vision et à son activité. Ces déclarations dépendent de certains risques connus ou non, d’incertitudes, ainsi que d’autres facteurs, qui pourraient conduire à ce que les résultats réels, les conditions financières, les performances ou réalisations de Pixium Vision diffèrent significativement des résultats, conditions financières, performances ou réalisations exprimés ou sous-entendus dans ces déclarations prospectives. Pixium Vision émet ce communiqué à la présente date et ne s’engage pas à mettre à jour les déclarations prospectives qui y sont contenues, que ce soit par suite de nouvelles informations, événements futurs ou autres. Pour une description des risques et incertitudes de nature à entraîner une différence entre les résultats réels, les conditions financières, les performances ou les réalisations de Pixium Vision et ceux contenus dans les déclarations prospectives, veuillez-vous référer au chapitre 4 « Facteurs de risques » du document de référence de la Société enregistré auprès de l’Autorité des marchés financiers sous le numéro R.18-085 le 26 mars 2018, lequel peut être consulté sur les sites de l’Autorité des marchés – AMF (www.amf-france.org) et de Pixium Vision (www.pixium-vision.com).
IRIS® est une marque déposée de Pixium-Vision SA
Pixium Vision est coté sur Euronext (Compartiment C) à Paris
ISIN: FR0011950641 ; Mnemo: PIX
Pixium Vision est intégré à l’indice Euronext CAC All Shares
Les actions Pixium Vision sont éligibles PEA-PME et FCPI

13/12/2018

Abiomed Invests $15 Million in Shockwave

Santa Clara, Calif. – December 11, 2018 – Shockwave Medical, a pioneer in the development and commercialization of intravascular lithotripsy to treat complex calcified cardiovascular disease, today announced an investment and collaboration agreement with Abiomed, Inc. As outlined by the agreement, Abiomed will invest $15 million in Shockwave and the two companies will collaborate on a training and education program in the United States and Germany focused on the benefits of complementary use of their respective technologies.
Shockwave’s intravascular lithotripsy (IVL) technology employs sonic pressure waves to safely crack vascular calcium within the vessel wall, which enables arteries to expand under low pressure and become more compliant. Shockwave markets its Shockwave M5 Peripheral Intravascular Lithotripsy Catheter in the United States and Europe. With increasing frequency, the Shockwave M5 catheter is being used in patients with heavily calcified Iliac arteries in order to facilitate the transfemoral delivery of sophisticated devices with catheters, including transcatheter heart valves (TAVR) and Abiomed’s Impella®. IVL enables this patient group to benefit from these life-saving therapies when they would otherwise be ineligible for the procedure or would be at increased risk for procedural complications. In Europe, Shockwave also markets its coronary catheter – Shockwave C2 – which is used to treat severely calcified de novo coronary artery disease.
“While we are still early in our commercial scaling both in the US and Europe, I am pleased with how positively our Shockwave technology has been received and how many different types of patients and vessels our customers are able to safely treat with our IVL system,” said Doug Godshall, President and CEO of Shockwave Medical. “We are delighted to be able offer patients our solution in combination with Abiomed’s Impella technology using a minimally invasive approach, which should meaningfully improve outcomes. With Abiomed’s best-in-class approach to training and education, Shockwave will be able to more efficiently increase awareness and introduce IVL to customers, which we believe will help them better treat their most challenging patients. We are encouraged to see the positive clinical response we have witnessed to date.”

About Shockwave Medical’s Intravascular Lithotripsy System
Shockwave Medical’s IVL System leverages similar principles to urologic lithotripsy, which has been used as a safe and effective treatment to break up kidney stones for several decades.

The generator produces energy that travels through the connector cable and catheter to an array of miniaturized lithotripsy emitters located near the calcified lesion. With the integrated balloon expanded to ultra-low pressure, a small electrical discharge at the emitters vaporizes the fluid within the balloon, creating a rapidly expanding bubble that collapses within microseconds. The bubble’s expansion and collapse generates a series of sonic pressure waves that travel through the fluid-filled balloon and pass through soft vascular tissue, selectively cracking any hardened calcified plaque inside the vessel wall. After the calcium has been fractured, the integrated balloon can be expanded, performing angioplasty safely at low pressures. To view an animation of the Intravascular Lithotripsy procedure visit
http://shockwavemedical.com.

About Shockwave Medical
Shockwave Medical, based in Santa Clara, Calif., is developing and commercializing innovative intravascular lithotripsy technology for the treatment of calcified peripheral vascular, coronary vascular and heart valve disease. For more information, visit www.shockwavemedical.com.

13/12/2018

• Funding will be used to further expand product capabilities and fuel company growth
• Industry-leader is bringing software abstraction and automation to biological R&D and manufacturing

12 December – LONDON – Synthace Ltd., the company behind the leading cloud software platform for automating and improving the success rate of biological research and development, today announced the closing of a $25.6m Series B financing round led by Horizons Ventures with additional investment from Luminous Ventures, SOSV and select other individual and large family office investors. Synthace will use the new funds to drive continued product development and build upon its cell and gene therapy customer base to accelerate global awareness of its solutions.
Synthace is a leader in Computer Aided Biology, a new paradigm that comprises two domains: the Digital and the Physical. The Digital, powered by artificial intelligence, includes software for designing and simulating biological systems, as well as methods of collating, structuring and analysing experimental data. The Physical, enabled by automation, includes systems that allow for the seamless transfer of biological designs into real ‘wet lab’ experiments via logistics simulation and execution.
In October 2018, Synthace launched a white paper, Computer Aided Biology: Delivering Biotechnology in the 21st Century which provides the most complete industry vision to date for how biological research will be transformed by an emerging ecosystem of cloud connected and digitally empowered research tools that augment human capabilities, accelerating the transition of biology towards becoming an engineering discipline.
Synthace CEO Tim Fell said: “Digital-to-physical workflows have transformed the semiconductor, aerospace, automobile and many other industries. Now it is the turn of the biotechnology industry, and we are grateful for the support of Horizons Ventures and our other new investment partners who share Synthace’s vision of how to facilitate that change.”
Patrick Zhang, of Horizons Ventures, commented: “We are at a pivotal point in the development and use of biotechnology. We believe that Synthace will lead the industry’s transition to Computer Aided Biology, owing to its truly disruptive and cutting-edge AI driven experiment design capability and experiment execution technology. We look forward to working with the team on this next exciting stage of Synthace’s development.”
Bob Wiederhold, Synthace Chairman, concluded: “The realization is setting in across industry and academia that the complexity of biology can only be properly addressed with advanced software and automation. This investment in Synthace is a significant step in turning that recognition into reality.”
This announcement follows previous distinctions from Gartner and the World Economic Forum, where the impact of the Synthace platform in enabling the Lab of the Future and Industry 4.0 was recognised.

About Synthace
Based in London, Synthace is developing Antha, a language and software platform specifically for biology that lets researchers aim higher and achieve better results, faster. Antha is designed to make reproducible and scalable workflows that can be readily edited and shared, and easily automated on labs’ existing equipment. With customers across pharma, agritech and industrial biotechnology Synthace has been recognised by the World Economic Forum as a Technology Pioneer that is helping shape the Fourth Industrial Revolution – a technological revolution that will fundamentally alter the way we live, work and relate to one another. For more information, visit: www.synthace.com.

13/11/2018

Bresso (MI), Italy – November 12, 2018 – EryDel SpA (www.erydel.com), a biotech company specializing in the development and commercialization of drugs and diagnostics delivered through autologous red blood cells, today announced the appointment of Stanley J. Musial as Chief Financial Officer, effective immediately.
« The addition of Stan to the management team comes at a critical time as EryDel further strengthens its management team, » remarked Dr. Luca Benatti, Chief Executive Officer of EryDel. « Stan’s financial leadership and industry expertise, as well as his significant fund-raising and transactional experience, are invaluable assets, as EryDel moves its pipeline through development and ultimately to the commercial market. »

Stan has held senior financial management positions for both publicly-held and privately-held companies, becoming experienced in executing growth strategies, raising capital, and mergers and acquisitions. Stan most recently spent nearly six years as Executive Vice President and Chief Financial Officer of Egalet Corporation, a fully integrated specialty pharmaceutical company focused on innovative treatments for pain, which Stan took public in 2014, and was part of a team that transformed the company from development stage to revenue generation. Prior to that,
Stan held the position of Chief Financial Officer at Prism Pharmaceuticals, Inc., Strategic Diagnostics, Inc., and similar positions with other biotechnology, medical device and healthcare services companies. Stan began his career with KPMG LLP, earned an MBA in finance from Temple University and a BS degree in accounting from the Pennsylvania State University, and is a Certified Public Accountant.

Mr. Musial commented, “EryDel has a robust platform and a diverse pipeline that should lead to multiple opportunities to address important unmet medical needs. I am excited to join the team and contribute to advancing these product candidates by pursuing financial and operational strategies that enable the company to navigate challenges successfully and achieve meaningful clinical, regulatory, and commercial milestones.”

About Ataxia Telangiectasia
Ataxia Telangiectasia (AT) is a rare genetic disease caused by biallelic mutations in the ataxia telangiectasia mutated (ATM) gene, for which no established therapy is currently available. ATM encodes a PI3Kinase protein shown to play a pivotal role in response to DNA damage and cell cycle control. Homozygosity for ATM mutations result in a multisystemic disorder, involving mainly the nervous and immune systems. The major clinical feature of AT is severe progressive neurodegeneration from early infancy. Specific features include progressive ataxia of the trunk and limbs, involuntary movements, oculomotor apraxia, difficulties with speech and swallowing, and delayed peripheral neuropathy. Other clinical features of patients with the classical phenotype include oculocutaneous telangiectasia, immunodeficiency with recurrent respiratory tract infections, radiosensitivity and an increased incidence of cancer.

About EryDel
EryDel SpA is a biotechnology company specialized in the development of drugs delivered through red blood cells (RBCs) by using a proprietary medical device technology. Its most advanced product, EryDex System (EDS) is under late stage development for the treatment of Ataxia Telangiectasia, a rare autosomal recessive disorder for which no established therapy is currently available. EryDex has received Orphan Drug designation for the treatment of AT both from the FDA and the EMA. A completed pilot Phase II trial in AT patients demonstrated statistically significant efficacy of EDS on both the primary and secondary efficacy measures. An international multi-center, Phase III pivotal study, ATTeST, is being conducted. EryDel has a pipeline of preclinical programs that use its proprietary RBC’s delivery technology for the treatment of other rare diseases.
The ATTeST project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 667946”.
Media contact: Emanuela Germi at +39 02 36504470 or emanuela.germi@erydel.com

16/10/2018

Bresso (MI), Italy – October 15, 2018 – EryDel SpA (www.erydel.com), a biotech company specializing in the development
and commercialization of drugs and diagnostics delivered through autologous red blood cells, today announced the
appointment of Ronan W. Gannon as Chief Commercial Officer, effective immediately.
“I am pleased to welcome Ronan to EryDel,” said Dr. Luca Benatti, Chief Executive Officer of EryDel. Ronan’s commercial
expertise in rare diseases and blood products will be critical as we advance our comprehensive development program
for EryDex, including our pivotal Phase 3 clinical study (ATTeST) in Ataxia Telangiectasia and seek to transition EryDel
from a late-stage research and development company to a commercial-stage organization. We look forward to his
contribution as a member of our leadership team.”
Ronan brings more than 25 years of industry experience across large, midsize and startup life science companies. Before
joining EryDel, Ronan led global commercial operations at Radius Health, where he helped transform the company from
a late-stage development startup into a fully integrated biopharmaceutical company. Prior to that, Ronan spent ten
years at CSL Behring where he held several leadership roles including US Vice President Marketing and North America
general management roles in the US and Canada. During his tenure at CSL Behring he launched six orphan drugs. Prior
to CSL, Ronan led sales and marketing teams at Zeneca Pharmaceuticals, and GlaxoSmithKline across several therapeutic
areas including biologicals, oncology, and asthma. He received an MBA from Northeastern University, a BA from the
University of Richmond and holds alumni status from the Harvard Business School.
« I am delighted to join EryDel as the company begins planning for the commercialization of EryDex,“ said Mr. Gannon.
“EryDel has played a significant role in developing an innovative treatment for Ataxia Telangiectasia, a life-threatening
disease. I look forward to working with the team to continue ongoing community and market development efforts, and
to advance a robust commercialization strategy for the launch of EryDex.”

About Ataxia Telangiectasia
Ataxia Telangiectasia (AT) is a rare genetic disease caused by biallelic mutations in the ataxia telangiectasia mutated
(ATM) gene, for which no established therapy is currently available. ATM encodes a PI3Kinase protein shown to play a
pivotal role in response to DNA damage and cell cycle control. Homozygosity for ATM mutations result in a multi-systemic
disorder, involving mainly the nervous and immune systems. The major clinical feature of AT is severe progressive
neurodegeneration from early infancy. Specific features include progressive ataxia of the trunk and limbs, involuntary
movements, oculomotor apraxia, difficulties with speech and swallowing, and delayed peripheral neuropathy. Other
clinical features of patients with the classical phenotype include oculocutaneous telangiectasia, immunodeficiency with
recurrent respiratory tract infections, radiosensitivity and an increased incidence of cancer.

About EryDel
EryDel SpA is a biotechnology company specialized in the development of drugs delivered through red blood cells (RBCs)
by using a proprietary medical device technology. Its most advanced product, EryDex System (EDS) is under late stage
development for the treatment of Ataxia Telangiectasia, a rare autosomal recessive disorder for which no established
therapy is currently available. EryDex has received Orphan Drug designation for the treatment of AT both from the FDA
and the EMA. A completed pilot Phase II trial in AT patients demonstrated statistically significant efficacy of EDS on both
the primary and secondary efficacy measures. An international multi-center, Phase III pivotal study, ATTeST, is being
conducted. EryDel has a pipeline of preclinical programs that use its proprietary RBC’s delivery technology for the
treatment of other rare diseases.
The ATTeST project has received funding from the European Union’s Horizon 2020 research and innovation programme
under grant agreement No 667946”.
Media contact: Emanuela Germi at +39 02 36504470 or emanuela.germi@erydel.com

08/10/2018

– Fast-emerging area of research with potential to treat severe diseases including cancer and autoimmune conditions
– Company’s proprietary science supported by drug discovery expertise within GSK

Oxford, UK – 8 October 2018 – Sitryx, a new biopharmaceutical company focused on regulating cell metabolism to develop disease-modifying therapeutics in immuno-oncology and immuno-inflammation, today announces it has closed its Series A financing round. The company, founded with seed funding from SV Health investors, raised a total of $30 million from a syndicate of specialist international healthcare investors co-led by SV Health Investors and Sofinnova Partners and that also included Longwood Fund and the global healthcare company GSK. The investment will be used to develop disease-modifying therapies in immuno-oncology and immuno-inflammation.
Immunometabolism is a fast-emerging area of investigation into the role of metabolic pathways in immune cell function. Changes to these pathways have been shown to be pivotal in the development of a number of severe diseases, including a range of cancer and autoimmune conditions. Correcting immune cell function and/or inhibiting tumour cell growth through immunometabolic therapies have the potential to be key, complementary and highly differentiated approaches to treating disease.
Sitryx is leveraging the world-leading scientific expertise of its founders in the field of immunometabolism to address a broad range of immunometabolic targets. Through differentiated chemistry approaches, including small molecules, proteolysis targeting chimera (PROTACS) and topical formulations, Sitryx has built a portfolio of projects addressing oncology and immuno-inflammatory indications. Sitryx’s proprietary science is supported through close working with GSK’s drug discovery and chemistry experts. This includes access to certain GSK technologies and the licensing of intellectual property, including chemical matter, from GSK. GSK’s interest in Sitryx arose from work within the Immunology Network, a unique open collaboration initiative connecting GSK to the work of academic scientists and their novel immunology research.
Sitryx was co-founded by a team of world-leading scientists from the United States and Europe, who have contributed significantly to the field. Co-founders comprise Houman Ashrafian, Partner at SV Health Investors; Luke O’Neill, Professor of Biochemistry, School of Biochemistry and Immunology at Trinity College Dublin; Jonathan Powell, Professor of Oncology and Associate Director, Institute for Cancer Immunotherapy, Johns Hopkins University; Jeff Rathmell, Professor of Cancer Biology and Director, Vanderbilt Center for Immunobiology; Michael Rosenblum, Assistant Professor, UCSF School of Medicine; and Paul Peter Tak, former Chief Immunology Officer and Senior Vice President at GSK and Professor of Medicine at Amsterdam University Medical Centre.
Sitryx has recruited a team of highly experienced drug discovery and development leaders including CEO Neil Weir, formerly SVP Discovery at UCB Pharma.
Neil Weir, Chief Executive Officer of Sitryx, said: “Immunometabolism is an extremely exciting and compelling scientific area and, at Sitryx, we have seen that modulation of these key cellular pathways has broad therapeutic potential across multiple disorders with unmet medical need, particularly in the areas of immuno-oncology and immuno-inflammation. We are delighted to welcome leading specialist investors to the company, which further validates the strength of our scientific expertise and ambitions.
Together with our proprietary chemistry, deep biological insights and world leading team of immunometabolism experts, Sitryx is well positioned to become a leader in immunometabolism.”
Richard Aldrich, General Partner of Longwood Fund, said: “We’re excited about our investment in Sitryx and their world class team. The Sitryx immunometabolism platform has the potential to yield major breakthroughs in inflammation and oncology.”
Houman Ashrafian, SV Health Investors, said: “This significant fundraise is clear validation of Sitryx’s expertise and ambitions in the fast-emerging area of immunometabolism. We’re very pleased to be able to support Sitryx at this exciting time and will follow the team’s scientific progress with interest.”
Maina Bhaman, Sofinnova Partners, said: “Sitryx represents an exciting opportunity in the promising area of immunometabolism and we are extremely pleased to invest in Sitryx and look forward to supporting the management team as it establishes Sitryx as a leader in the development of disease-modifying therapeutics in immuno-oncology and immuno-inflammation.”
John Lepore, Senior Vice President Research, GSK, said: “Immunology is at the heart of GSK’s new approach to R&D. Through our Immunology Network, we believe the emerging field of immunometabolism that Sitryx is focusing on has the potential to bring new therapeutic opportunities to patients for a broad range of diseases including cancer. Our investment in Sitryx will allow us to access this exciting science through working closely with world-renowned academic scientists in an open collaborative way.”

For more information about Sitryx please contact:
Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Melissa Gardiner
+44 (0)20 3709 5700
sitryx@consilium-comms.com

About Sitryx
Sitryx is a biopharmaceutical company focused on regulating cell metabolism to develop disease-modifying therapeutics in immuno-oncology and immuno-inflammation.
The field of immunometabolism is a rapidly emerging and exciting area and offers new insights into the role of intracellular metabolism in regulation of the immune response.
The energetic status of cells has been shown to be pivotal in controlling the behaviour of disease-associated cells in immuno-oncology and immuno-inflammation. Correcting immune cell function and/or inhibiting tumour cell growth through targeting metabolic pathways has the potential to deliver new complementary and highly differentiated approaches to treat a wide range of severe diseases.
Sitryx’s proprietary science is led by a highly experienced management team, supported by GSK’s drug discovery experience and world class academic founders. Sitryx was founded by six world-leading researchers in the field of immunology and metabolism including Houman Ashrafian, Luke O’Neill, Jonathan Powell, Jeff Rathmell, Michael Rosenblum and Paul Peter Tak. Together they have published
more than 1,000 papers in the field, making multiple key breakthroughs in our understanding of how critical energetic status is to the behaviour of immune cells and in the broader field of immunology.
In 2018, Sitryx raised $30 million Series A funding from an international syndicate of specialist investors including SV Health Investors, Sofinnova Partners, Longwood Fund and GSK. The company has a pipeline of projects at multiple stages of drug discovery. Sitryx is headquartered in Oxford, UK. For more information, please visit www.sitryx.com

02/10/2018

• The study demonstrated the safety and tolerability of its lead compound in patients suffering from septic shock

Paris, October 1st. 2018. Inotrem S.A., a biotechnology focused on the modulation of the TREM pathway for the management of inflammatory syndromes, announced positive results for its Phase IIa study that demonstrated the safety and tolerability of its lead product candidate, nangibotide (LR12), in septic shock patients. The results were presented today at the annual congress of the International Sepsis Forum in Bangkok.
Septic shock is the ultimate complication of sepsis and currently constitutes an unmet medical need. The incidence of septic shock continuously raises and mortality remains elevated (35%) in developed countries. There is currently no specific therapy approved for this indication besides antibiotics and symptomatic agents, and Inotrem’s solution has the potential to become the first mechanism-based treatment for septic shock. Nangibotide is developed by Inotrem and is based on a novel approach of immunomodulation: it specifically targets the TREM-1 pathway which is crucial mediator of the septic shock.
The reported study was an 11-months multicenter phase IIa clinical trial with 49 patients suffering from septic shock enrolled in four European countries (Belgium, France, The Netherlands and Spain). The results bring positive data on the safety and tolerability of Inotrem’s lead product candidate, nangibotide, in septic shock patients. The study also showed that nangibotide treatment provided consistent trends in a more favorable evolution of biological and clinical activity markers in the subgroup of patients with soluble TREM-1 levels above median at entry. These results support Inotrem’s personalized medicine approach: using soluble TREM-1 level in blood as a potential biomarker for the identification of patients who will most likely benefit from nangibotide treatment. The results from this clinical trial reinforce previous preclinical and clinical findings, in particular about the safety, biological and clinical activity of nangibotide and the use of sTREM-1 as a companion biomarker for patient selection. Consequently, the company intends to launch in 2019 a Phase IIb study, with the aim to bring a strong proof of clinical activity of nangibotide in septic shock patients.
Jean-Jacques Garaud, CEO of Inotrem said: “These results are very encouraging for septic shock patients and confirms the therapeutic potential of our novel personalized approach based on immunomodulation targeting the TREM-1 pathway.”
Bruno François, MD, from the Limoges University Hospital, Coordinating Investigator of the study, added: “These positive data open promising and interesting prospects on a severe and often life-threatening disease, that currently has no approved targeted therapy”.
Inotrem previously announced it was granted access to EMA’s priority medicines scheme (PRIME) for its lead compound nangibotide (LR12) in the treatment of septic shock. In parallel, Inotrem is developing in partnership with Roche Diagnostics a quantitative assay for the biomarker sTREM-1, paving the way to a personalized healthcare approach in critical care medicine.

Media contact for Inotrem
Anne REIN | S&I | anne.rein@strategiesimage.com | +33 6 03 35 92 05
For more information about Inotrem’s Phase 2a study, please refer to the abstract published in Intensive Care Medicine Experimental: Safety and pharmacodynamic activity of a novel TREM-1 pathway inhibitory peptide in septic shock patients phase IIa clinical trial results, Bruno François et al, Intensive Care Medicine Experimental 2018, 6(Suppl 1): P1.

About Nangibotide
Nangibotide is the formulation of the active ingredient LR12, which is a 12 amino-acid peptide prepared by chemical synthesis. LR12 is a specific TREM-1 inhibitor, acting as a decoy receptor and interfering in the binding of TREM-1 and its ligand. TREM-1 pathway is an amplification loop of the immune response that triggers an exuberant and hyperactivated immune state which is responsible for the onset and progression of sepsis. In preclinical septic shock models, nangibotide was able to restore appropriate inflammatory response, vascular function, and improved animals’ survival post septic shock.

About Inotrem
Inotrem S.A. is a biotechnology company specialized in for the control of acute inflammatory syndromes, such as septic shock. The company has developed a new concept of immunomodulation that targets the TREM-1 pathway to control unbalanced inflammatory responses. Through its proprietary technology platform, Inotrem has developed the first-in-class TREM-1 inhibitor, LR12 (nangibotide), with applications in a number of therapeutic indications such as septic shock and myocardial infarction. In parallel, Inotrem has also launched another program to develop a new therapeutic modality targeting chronic inflammatory diseases. The company was founded in 2013 by Dr. Jean-Jacques Garaud, a former head of research and early development at the Roche Group, Prof. Sébastien Gibot and Dr. Marc Derive. Inotrem is supported by leading European investors — Sofinnova Partners, Andera Partners (previously Edmond de Rothschild Investment Partners), Biomed Invest and Inserm Transfert Initiative.
www.inotrem.com

12/09/2018

LEIDEN, Netherlands and CAMBRIDGE, Mass., Sept. 11, 2018 — ProQR Therapeutics N.V. (Nasdaq:PRQR), a biopharmaceutical company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases, today announced the closing of its previously announced underwritten public offering of 6,612,500 ordinary shares at a price to the public of $15.75 per share. The closing included the full exercise of the underwriters’ option to purchase 862,500 additional ordinary shares at the public offering price, less underwriting discounts and commissions. Gross proceeds from the offering totaled approximately $104.1 million, before deducting underwriting discounts and commissions and offering expenses.
Citigroup, Evercore ISI and RBC Capital Markets acted as joint bookrunners for the offering. H.C. Wainwright & Co. and Chardan acted as co-managers for the offering. Kempen & Co acted as the Company’s European financial advisor in relation to this offering.
A shelf registration statement relating to the offered ordinary shares was filed with the Securities and Exchange Commission (SEC) on October 2, 2015, which was declared effective on October 19, 2015. A prospectus supplement and accompanying prospectus related to the offering have been filed with the SEC and are available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Evercore ISI, Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474-0200 or by email at ecm.prospectus@evercore.com; or RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281, or by telephone at (877) 822-4089, or by email at equityprospectus@rbccm.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About ProQR
ProQR Therapeutics is dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases such as Leber’s congenital amaurosis 10, dystrophic epidermolysis bullosa and cystic fibrosis. Based on our unique proprietary RNA repair platform technologies we are growing our pipeline with patients and loved ones in mind.
*Since 2012*

Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, statements about ProQR’s business and efforts to develop RNA medicines. These forward-looking statements involve risks and uncertainties, many of which are beyond ProQR’s control. Applicable risks also include those that are included in ProQR’s prospectus supplement and accompanying prospectus filed with the SEC for the offering, including the documents incorporated by reference therein, which include ProQR’s Annual Report on Form 20-F for the year ended December 31, 2017, and any subsequent SEC filings. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

ProQR Therapeutics N.V.:
Smital Shah
Chief Financial Officer
T: +1 415 231 6431
ir@proqr.com