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PRESS RELEASE / 15.09.2022

TRiCares Raises €47m in a First Closing of its Series C Financing to Fund Further Development of Minimally Invasive Treatment for Tricuspid Regurgitation

Paris, France and Munich, Germany, September 15, 2022 -- TRiCares SAS (“TRiCares”) a privately held pioneer in the field of minimally invasive treatment of tricuspid regurgitation, is pleased to announce today that it has successfully raised €47m from the first closing of its Series C financing round. The completion of the Series C financing round is expected later this year.

The proceeds of this financing will primarily be used to continue the development of the company’s transfemoral tricuspid heart valve replacement system (“Topaz”) up through to the application for a pivotal investigational device exemption (“IDE”) trial in the United States. To this end, TRiCares plans to initiate an early feasibility study across five centers in the US in 2023

The proceeds of this financing will also support the on-going TRICURE first-in-human clinical study in Belgium as well as potential additional clinical trial applications elsewhere in Europe, along with further compassionate use implantations as appropriate.

The Series C financing was led by 415 Capital and strongly supported by existing investors Andera Partners, BioMed Partners, Credit Mutuel Innovation, GOCapital, Karista and Wellington Partners. Total gross proceeds of €47m include a significant majority of new cash as well as the conversion of certain convertible loans issued prior to 2022.

TRiCares is developing a transcatheter-based tricuspid valve replacement system aimed at addressing the need for a better treatment for this frequent and severe disease that avoids open heart surgery. Heart valve diseases are among the most serious cardiac conditions, affecting more than 12.7 million patients in Europe and many more worldwide. Owing to high mortality risk, access to open heart surgery is severely restricted and is not considered an option for more than 99% of patients with tricuspid regurgitation, leaving surgeons seeking minimally invasive, lower risk solutions to improve outcomes for patients with no other viable treatment options

Topaz is an innovative device designed specifically to help patients suffering from severe tricuspid regurgitation without the need for open heart surgery. The Topaz device is implanted in a minimally invasive procedure through the patient’s femoral vein. It is designed specifically to fit the tricuspid valve anatomy and thus supports ease of positioning and functionality.

Helmut J. Straubinger, Chief Executive Officer of TRiCares, said: “This successful financing reflects the tremendous potential of the Topaz tricuspid valve replacement system, our continued progress in its development and strong support from investors for our strategy. As we seek to deliver a much-needed solution for patients with tricuspid regurgitation, we look forward to the further development of the Topaz system with a focus on the necessary preparations for a pivotal IDE trial in the US along with continuing to progress our clinical activities in Europe.”

Frederik Groenewegen, General Partner at 415 Capital, commented: “TRiCares is developing what we believe has the potential to become a best-in-class therapy option to restore quality of life for millions of patients suffering from tricuspid regurgitation. We have been encouraged by the early clinical experience with the TRiCares device and look forward to supporting the team as they work towards making their technology available to patients in the United States and Europe.”

Sofia Ioannidou, PhD, Partner at Andera Partners, commented: “The pioneering work that TRiCares is doing has the potential to save the lives of millions of patients around the world with tricuspid regurgitation who currently have no effective long-term treatment options. We are excited to continue accompanying TRiCares in its journey to develop a safe and effective transcatheter valve replacement system for these patients.”

Regina Hodits, PhD, Managing Partner at Wellington Partners, said: “We see that the Topaz tricuspid valve replacement system has the potential to become the global standard of care for patients suffering from tricuspid regurgitation. We are proud to continue supporting TRiCares as it progresses the development of its Topaz system towards the market.”



About TRiCares
TRiCares is a young medical device startup company located in Paris and Munich having the vision to bring to the market a transfemoral tricuspid valve replacement system. This system aims at helping patients suffering from severe tricuspid regurgitation (TR) without the need for open heart surgery. The experienced team of TRiCares is supported by the leading European life science venture capital firms: Andera Partners, BioMed Partners, Credit Mutuel Innovation, GoCapital, Karista, Wellington Partners and 415 Capital

About Tricuspid Regurgitation (TR)
The tricuspid valve is the heart valve that regulates the blood between the right atrial and ventricular chamber. Tricuspid regurgitation occurs when the tricuspid valve fails to close properly, causing blood to flow backwards into the right atrium. Tricuspid regurgitation is a frequent problem and a severe disease that was neglected for many years, leading to a large number of untreated patients without an effective treatment option. Cardiac surgeons and interventional cardiologists have long waited for a transcatheter based solution. The progress in developing minimally invasive treatment options for heart valves as well as the experience gained in numerous research projects has strongly increased the awareness of the importance of this disease

About the Medical Need
Heart valve diseases are among the most serious cardiac complications affecting at least 12.7 million patients in Europe and many more worldwide. In the last decade, innovative minimally invasive catheter-based solutions have been developed for the treatment of aortic and mitral heart valve disease, creating a fast-growing transcatheter heart valve replacement market. However, for patients with tricuspid heart valve disease (tricuspid regurgitation), no solution exists to replace the diseased heart valve due to anatomic, functional and technological challenges. Only repair options by so-called clipping devices have been developed. But this technique is not suitable for all patients and the treatment success is limited. Consequently, open-heart surgeries to repair the insufficient valve and medical treatments still represent the standard treatment options. Due to excessive risk of the procedures (10–35 % surgical mortality), more than 99 % of TR patients are considered ineligible for the curative surgeries and are only maintained on symptomatic pharmacologic treatment with poor prognosis (2.2 years median survival). Therefore, physicians are urgently seeking minimally invasive, low-risk solutions to improve clinical outcomes in TR patients.

PRESS RELEASE / 28.02.2022

SUPIRA MEDICAL, A SHIFAMED PORTFOLIO COMPANY, CLOSES $30M IN AN OVERSUBSCRIBED SERIES C FINANCING

LOS GATOS, Calif., Feb. 28, 2022 /PRNewswire/ -- Supira Medical, Inc., a Shifamed portfolio company that is focused on developing a next-generation solution for temporary mechanical circulatory support, announced today the closing of $30M in Series C financing. Led by Cormorant Asset Management and The Capital Partnership (TCP), with participation from 415 CAPITAL, AMED Ventures, PA MedTech VC Fund and Shifamed angel investors, the funds will be used to finalize product development and initiate a first-in-human clinical study for the company's high-flow, low-profile percutaneous ventricular assist device (pVAD).

"We are extremely pleased to close this round of financing with strong, continued support from our investors. This investment will further refine our technology platform that aims to minimize vascular complications and improve outcomes for high-risk PCI and cardiogenic shock patients," commented Dr. Nitin Salunke, President and CEO of Supira Medical. "As we plan for our upcoming milestones, we look forward to initiating our first-in-human experience and gaining these valuable clinical insights."

Percutaneous ventricular assist devices (pVADs) are used during stent placement or angioplasty to provide temporary mechanical support for high-risk patients with severe coronary artery disease or comorbidities. Additionally, pVADs are used to treat patients suffering from cardiogenic shock (CS), a condition that can occur following a severe heart attack, and is associated with a high rate of morbidity as a patient's heart is suddenly too weak to adequately pump blood to vital organs.

"Temporary mechanical support enables a high-risk patient to undergo necessary interventions that their heart would otherwise not be able to tolerate. Despite current offerings, there is significant opportunity for further innovation in this large and growing market," stated Bihua Chen, Founder and Managing Member of Cormorant Asset Management. "We are pleased to further invest in Supira Medical and are confident that the company's novel approach will be a meaningful solution for physicians and patients."

About Supira Medical, Inc.
Supira Medical, a privately held portfolio company of Shifamed, is focused on development of a next generation percutaneous ventricular assist device (pVAD) for use in high-risk patients undergoing interventional procedures. To learn more about Supira Medical, please visit www.supiramedical.com.

About Shifamed, LLC.
Founded by serial entrepreneur Amr Salahieh, Shifamed is a highly specialized medical innovation hub focused on developing solutions that accelerate time to market, reduce risk, increase impact, and forge a path toward a world where patients are able to lead longer, healthier lives. To learn more about Shifamed, please visit www.shifamed.com.

PRESS RELEASE / 26.01.2022

Distalmotion raises $90M to accelerate adoption of surgical robot Dexter

Lausanne/Austin/Munich, 26 January 2022: Distalmotion announced today the closing of a USD 90 million Series E financing to support the global commercialization of its surgical robot Dexter. Revival Healthcare Capital (Revival) led the round with participation from 415 CAPITAL (415), as well as existing investors.

CE-marked Dexter shifts the paradigm of robotic surgery by bringing the surgeon back into the sterile field, allowing direct patient access at all times and integrating proven laparoscopic workflows into the robotic setup. This novel, user-centric approach makes the surgeon the focal point of the procedure, reducing complexity and delivering sought-after simplicity and versatility to the market for robotic surgery.

“Dexter combines the best of both worlds – laparoscopy and robotics – to make sense of robotic surgery,” said Distalmotion CEO Michael Friedrich. “By addressing essential problems that operating room teams face, we can deliver on our mission to fast-track widespread adoption of robotic surgery in minimally invasive care. We are thrilled to have found the best-fitting partners to execute and deliver on this global purpose.”

The investment follows the successful completion of Dexter’s first clinical cases and aims to accelerate the Swiss company’s commercial scaling. Leading European hospitals are spearheading the development of procedure guidelines and training protocols for robotic surgery with Dexter as part of clinical studies and an Early Adopter Program (EAP). The company will also work closely with the U.S Food and Drug Administration (FDA) on a US submission supported by the financing.

“This is a fundamentally new approach to robotic surgery,” said Prof. Dieter Hahnloser, who heads colorectal surgery at Lausanne University Hospital and performed the worldwide first general surgery procedure with Dexter in 2021. “Dexter’s open platform and the ability to switch quickly between standard laparoscopy and the robot give me an added sense of control and the freedom of choice to use the best instruments available for the job. To have these benefits while remaining sterile, with direct access to patient and robot, indicates Dexter can be a gamechanger in ORs around the world.”

In addition to financial backing, Revival will contribute hands-on leadership as the company gears up for growth: Revival Chairman Rick Anderson will join the Distalmotion board as Chairman, while President Lauren Forshey will join as an observer.

“The market is overdue for a fundamentally new approach to robotic surgery, where the mindset needs to be about ‘the surgeon’s robot,’ not molding ‘the robot’s surgeon,’” said Rick Anderson, Revival Chairman and incoming Chairman of Distalmotion. “Dexter is designed to work the way surgeons and OR teams work: patient focused and user-centric, providing necessary patient access and optimal tools for every step of the way. We are excited to deliver this powerful value proposition to surgeons, OR teams, and patients worldwide.”

About Distalmotion
Distalmotion is a medical device company founded and based in Lausanne, Switzerland. Our mission is to remove the complexity out of robotic surgery in order to establish a new standard of care, where all patients in general surgery, gynecology and urology have access to best-in-class minimally invasive care. To do so, we have developed a surgical robot called Dexter. Designed, developed and manufactured in Switzerland, Dexter integrates the benefits of laparoscopy and robotics. Dexter combines the affordability of laparoscopy with the benefits of robotics through his novel approach to robotic surgery. For further information, visit: dexter.surgery and follow us on LinkedIn and Twitter: @Distalmotion.

PRESS RELEASE / 02.11.2021

Aktiia closes $17.5 million Series A financing round

Aktiia’s automated Optical Blood Pressure Monitoring System for 24-7 use at the wrist reports accelerating sales growth in the United Kingdom, Ireland, Germany, Austria, Switzerland, France and Italy. The funds will be used to fuel growth in these markets and to obtain FDA clearance.



Draper Esprit leads the US$ 17.5m Series A investment in hypertension health-tech firm Aktiia. Additional Investors participating in the round include 415 Capital, Redalpine Venture Partners, Verve Ventures and Silicon Valley-Based Translink Capital.

The new capital will be used to expand Aktiia’s commercial footprint in the NHS and key healthcare markets across Europe and to build out a team focusing on the healthcare channel. A percentage of the Series A funds will also go towards obtaining FDA clearance to enable expansion to the US market, following Aktiia's reception of the CE Mark as a Class IIa medical device in Europe, signifying that the device has been assessed to meet high safety, health and environmental protection requirements.

Dr Inga Deakin, principal, Draper Esprit said: “Aktiia has built a rigorously tested, non-invasive, automated blood pressure monitoring system at the wrist, providing a comprehensive, longitudinal picture of hypertension in patients. Their strong clinical validation, patient engagement, and market traction are extremely impressive and give us every confidence that Aktiia will transform how hypertension is measured and managed globally.”

Professor Melvin Lobo, NHS Professor of Cardiovascular Medicine and Director of St. Bartholomew’s Hospital Blood Pressure Clinic commented: “I believe we are only scratching the surface of the possible applications for the long-term 24/7 blood pressure data that Aktiia is uniquely capable of providing to physicians. This is an indisputable game changer in enabling a better understanding of our patients’ blood pressure patterns and how to treat them on a personalized basis.”

PRESS RELEASE / 20.06.2021

MedTech VC Firm 415 CAPITAL Announces Strategic Alliance With European Healthcare Service Provider Uniphar Group PLC

MedTech VC Firm 415 CAPITAL Announces Strategic Alliance With European Healthcare Service Provider Uniphar Group PLC

Partnership formed on the back of Uniphar Group PLC’s acquisition of CoRRect Medical GmbH, a leading Germany-based distributor of innovative medical device technologies, co-founded by 415 CAPITAL’s partners



415 CAPITAL Management GmbH (“415 CAPITAL”) today announced that it has entered into a strategic alliance with Dublin-based Uniphar Group PLC, a diversified international healthcare service provider and distributor of pharma and medical device products. Uniphar Group PLC is headquartered in Dublin, Ireland with over 3,000 employees and presence across Ireland, U.K., Benelux, the Nordics and the U.S.

“As an early- and development-stage medical technology investor, we have always been focused on leveraging our clinical and commercial access to create value for our portfolio companies,” added Frederik Groenewegen, Co-Founder & Managing Director of 415 CAPITAL. “For our investment franchise, this new strategic alliance is a huge leap forward, as it provides us with significantly expanded clinical and commercial reach across complementary European geographies, as well as access to a large clinical and retail sales infrastructure that supports almost €2 billion in annual revenues.”

The partnership was formed on the back of Uniphar Group PLC’s acquisition of CoRRect Medical GmbH, a leading distributor of innovative medical devices in Germany and Switzerland, co-founded by Michael Braun, Frank Groenewegen and David Thompson in 2010. The CoRRect Medical acquisition constitutes Uniphar Group PLC’s entry into Europe’s largest and most important healthcare market, Germany, and also adds activities in Switzerland. CoRRect Medical GmbH will further complement the Uniphar Group’s existing strong position within the interventional space across a number of brands: EPS Vascular, Angiocare, M3, Synapse Medical and MacroMed.

Following the acquisition, Michael Braun will remain as CoRRect Medical’s CEO and also continue to serve as a Senior Venture Partner of 415 CAPITAL, thereby acting as a close link between the medical technology VC and the healthcare services powerhouse. In addition, 415 CAPITAL Managing Director David Thompson will serve on a newly established strategy committee established between both groups. “We will be working closely with Uniphar Group to continuously explore and realize value-creation opportunities between our investment portfolio and the Uniphar Group of companies,” said Mr. Thompson.

About 415 Capital
415 CAPITAL is a leading medical technology venture capital firm that was formed by entrepreneurs and investors who share a 28-year history of funding and commercializing groundbreaking medical technologies. The team has invested in more than 50 medical technology startups over the years, realizing over 25 exits to date, including Intact Vascular (sold to Philips in 2020), ReBound Therapeutics (sold to Integra LifeSciences in 2019), Claret Medical (sold to Boston Scientific in 2018), ReCor Medical (sold to Otsuka Holdings in 2018), ImThera Medical (sold to LivaNova in 2018), CardiAQ Valve Technologies (sold to Edwards Lifesciences in 2015), and CoreValve (sold to Medtronic in 2009).

About Uniphar Group PLC
Headquartered in Dublin, Ireland, Uniphar Group PLC is an international diversified healthcare services business servicing the requirements of more than 200 multinational pharmaceutical and medical technology manufacturers across three divisions - Commercial & Clinical, Product Access, and Supply Chain & Retail. The Group has strong established relationships with 7 of the top 10 pharma companies and 6 of the top 10 medical device companies. With a workforce of more than 3,000, the Group is active in Ireland, the U.K., the Benelux, the Nordics and the US, delivering unlicensed and specialty medicine on a global basis. The Group's vision is to improve patient access to pharmaco-medical products and treatments by enhancing connectivity between manufacturers and healthcare stakeholders. Uniphar Group represents a strong combination of scale, growth and profitability.

PRESS RELEASE

Uniphar to buy CoRRect Medical as it accelerates entrance to German market

German company focuses on interventional cardiology



Uniphar is to buy Germany-based CoRRect Medical as it accelerates its entrance into the German market and expands in Europe.

The purchase price was not disclosed, but is believed to be around €25 million and includes an upfront payment plus further consideration payable upon achievement of performance targets.

The company commercialises and distributes medical device products in the cardiology sector across Germany and Switzerland, focusing on the fastt growing areas of interventional cardiology, including structural heart.

The acquisition is seen as a milestone for Uniphar, with Germany representing the largest medtech market in Europe.

“The acquisition of CoRRect Medical accelerates our entry into Germany, the largest MedTech market in Europe, and underpins our focus on developing a truly pan-European offering for our partners,” Ger Rabbette, CEO of Uniphar said. “CoRRect Medical’s strong relationships with German and Swiss physicians and hospitals, combined with Uniphar’s expertise and deep manufacturer relationships, will provide a unique offering for MedTech customers seeking to commercialise across Europe.”

The acquisition is forecast to deliver a return on capital employed to the group in line with Uniphar’s target rate of 12 per cent to 15 per cent within three years.

Michael Braun, Managing Director of CoRRect Medical said the acquisition would allow the company to continue to grow in the interventional cardiology space as well as explore new opportunities. “This represents the beginning of an exciting new chapter for CoRRect Medical, our growing team of 11 high performing individuals and our partners,” he said.

By Ciara O'Brien for www.irishtimes.com

PRESS RELEASE / 23.06.2021

Israeli Medical Device Startup, Cardiac Success Ltd., Closes US $5.2M Series A Financing


The round was led by 415 CAPITAL, a specialist medical technology venture capital firm who was joined by an unnamed strategic investor and global leader in structural heart interventions. Proceeds will be used for pre-clinical testing and the completion of a First-in-Human trial of the company’s innovative “V-sling” heart failure therapy.



YOKNEAM, ISRAEL (PRWEB), June 23, 2021 – Cardiac Success Ltd., an Israel-based medical device company developing a transcatheter ventricular repair device for heart failure patients, today announced the successful closing of a US $5.2 million Series A financing round led by 415 CAPITAL, a specialist VC firm that primarily backs innovative medical technology companies in the cardio-and neurovascular space. The round was joined by an unnamed global strategic leader in structural heart interventions and a group of Israeli angel investors.

Despite guidance-directed medical therapy, heart failure continues to be a serious and common health condition that affects millions of patients and carries high rates of rehospitalizations and deaths. Founded in 2017 in the Alon Medtech Ventures’ incubator, Cardiac Success Ltd. has developed the “V-sling” system, which aims to provide a new treatment approach by transforming an invasive open-heart surgery into a safe and effective minimally-invasive transcatheter procedure. Using the “V-sling” may significantly improve patients’ quality of life while reducing hospitalization time and costs.

The “V-sling” system is a safe anchorless implant to treat left ventricular dysfunction, where the left ventricle is not able to pump enough blood out of the heart leading to reduced ejection fraction and low cardiac output. The “V-sling” treats the problem directly at its source by repositioning the papillary muscles and restoring the conical shape of the left ventricle for improved cardiac function.

The functionality of the implant and delivery system has been demonstrated in pre-clinical studies. Cardiac Success has 4 granted United States (U.S.) patents, as well as additional patents pending in the U.S., Europe and other countries, protecting methods of treatment and the implant design.

Boaz Manash, CEO of Cardiac Success, said, “There are millions of patients who, despite guidance-directed medical therapy, continue to suffer and deteriorate from Heart Failure with Reduced Ejection Fraction (HFrEF).” Mr. Manash added, “This new funding from experienced investors and strategic partners in the cardiac field, shows their confidence in the “V-sling” system and will enable us to accelerate our clinical development to provide a treatment option for these heart failure patients.”

Cardiac Success Board chairman and Alon Medtech founder, Shimon Eckhouse, added: “Cardiac Success started in our Alon-Medtech Ventures group a few years ago with a high-risk concept based on out-of-the-box thinking of its founders. The first few years of the company's life were dedicated to significant risk reduction and turning the dream of its founders into a new transcatheter procedure that has the potential of revolutionizing the way heart failure is treated. We are proud and happy to have this top-notch group of new partners in the company.”

About Cardiac Success
Headquartered in Yokneam, Israel, Cardiac Success was founded in 2017 in the Alon Medtech Ventures’ incubator by the serial entrepreneur Dr. Shimon Eckhouse and Dr. David Neustadter (Chief Technology Officer). The company’s management team includes Mr. Boaz Manash (CEO), an experienced R&D leader previously responsible for the Sapien M3 mitral valve program at Edwards Lifesciences (NYSE: EW) and Prof. Rafael Beyar (Chief Medical Officer), an internationally-recognized cardiologist and former director of Rambam Medical Center. For more information, see https://www.cardiacsuccess.com/

About 415 CAPITAL
415 CAPITAL is a specialist venture capital firm that was formed by MedTech entrepreneurs and investors who share a 28-year history of funding and commercializing groundbreaking medical technologies. The team has invested in over 45 medical technology startups over the years, realizing over 25 exits to-date including Intact Vascular (sold to Philips in 2020), ReBound Therapeutics (sold to Integra LifeSciences in 2019), Claret Medical (sold to Boston Scientific in 2018), ReCor Medical (sold to Otsuka Holdings in 2018), ImThera Medical (sold to LivaNova in 2018), CardiAQ Valve Technologies (sold to Edwards Lifesciences in 2015), and CoreValve (sold to Medtronic in 2009). For more information, see https://415capital.com/

PRESS RELEASE / 04.02.2021

415 CAPITAL: Informing Early-Stage Investing with Distribution Expertise

ARTICLE SUMMARY:
While the combination of distributor and investor seems an unlikely one, the principals of 415 CAPITAL believe that their historic role as one of Germany’s leading distributors of cardiovascular technologies gives them a special insight into the opportunities start-ups face, insights that few early-stage investors have.

PRESS RELEASE / 27.01.2021

Interventional Robotics Startup Moray Medical Secures $3.3 Million Seed Financing Led by 415 CAPITAL

Company also elects new board member



MOUNTAIN VIEW, Calif., January 27, 2021 – Moray Medical announced today that it has raised $3.3 million in seed funding led by 415 CAPITAL, which invested alongside a number of prominent medtech entrepreneurs.

Moray is developing the CoralTM system, a novel interventional robotics platform powered by microfluidics and an augmented reality (AR) digital user interface. While the platform promises to dramatically simplify a wide range of minimally invasive cardiovascular interventions, Moray is initially focused on the rapidly growing transcatheter mitral valve repair (TMVR) market.

“While transcatheter edge-to-edge repair (TEER), or clip therapy, is rapidly becoming the new clinical standard of care, the complexity and learning curve associated with current devices means that the vast majority of needy patients are being left untreated,” said Mark Barrish, CEO and Co-Founder of Moray Medical. “Our platform is aimed at empowering interventionalists at all skill levels to carry out these procedures in a cost-efficient manner to ensure that millions of additional sick patients get the life-saving treatment they deserve.”

Moray also announced that 415 CAPITAL’s Senior Venture Partner, Dr. Azin Parhizgar, has joined Moray’s Board of Directors. Dr. Parhizgar is Chairwoman of CVPath Institute and a Board Member of Soundbite Medical Solutions and InnovHeart. She was previously CEO, President and Board Member at Claret Medical, an embolic protection device company acquired by Boston Scientific.

”Moray’s interventional robotics platform is designed to be a disruptive technology that will enable complex 3D structural heart and other interventional procedures to be performed with precision, accuracy, and efficiency. This enablement will be transformative to how such interventional procedures may be performed in the future, in person or remotely,” said Dr. Parhizgar.

PRESS RELEASE / 08.10.2020

R3 Vascular Inc. Completes Series A Financing

$17.8 million in proceeds will fund clinical development of innovative devices to treat peripheral artery diseases (PAD) such as CLI



MOUNTAIN VIEW, Calif., October 8, 2020 – R3 Vascular Inc. today announced closing of its Series A financing round, including new equity investments of $15 million and the conversion of $2.8 million of convertible notes. The round was led by an unnamed corporate investor and 415 CAPITAL, with participation from HBM-MedFocus LLC and Wexford Capital. Proceeds will support the company's clinical trial work in developing a next generation of below-the-knee (BTK) interventional therapies for PAD.

“We are excited about this investment in the company’s future,” said Jack Springer, Executive Chairman of R3 Vascular. “The number of patients suffering from BTK vascular disease is growing significantly for many reasons, including a large global increase in diabetes and obesity. These factors, along with others, are leading to a rapid rise in critical limb ischemia (CLI), a severe form of PAD. The physician community has been waiting far too long for a more safe and effective way to treat BTK disease.

“I am further pleased to announce that Kamal Ramzipoor will join R3 Vascular as CEO,” said Mr. Springer. “Kamal has extensive experience in building and leading both early-stage and large medical device companies. In particular, he is a hands-on leader with extensive experience in developing and commercializing polymer-based drug/device combination products.”

Mr. Ramzipoor added, “The unique mechanical properties and polymer technology of R3 Vascular’s proprietary bioresorbable scaffold, already validated in multiple clinical trials, offer differentiating features compared to other bioabsorbable scaffolds. It is becoming clear that the use of scaffold support offers a potential competitive advantage compared to other balloon-based therapeutic approaches in BTK interventions. R3 Vascular’s polymeric technology is the only platform that has achieved ‘DES-like’ mechanical performance at the sub-100-micron level across all scaffold diameters.”

Dr. Juan F. Granada, a key strategic advisor to R3 Vascular, stated that “A resorbable sirolimus-eluting device provides the best of both worlds for this type of patient: acute mechanical support, long-term lumen patency and progressive resorption allowing vessel re-intervention in case it is needed. The superior mechanical performance of the R3 Vascular bioresorbable platform has the potential to shift the therapeutic approach for patients suffering from CLI.”

RM Global Partners LLC served as advisor to R3 Vascular Inc.

About R3 Vascular Inc.

R3 Vascular is a privately held, early-stage medical device company that has created a novel technology platform for developing and manufacturing fully bioresorbable vascular scaffolds (BVS) technology with a sirolimus coating for the treatment of PAD below the knee. The R3 Vascular BVS platform combines the best of both worlds of BTK therapy, designed to deliver the ‘stent-like’ support of a scaffold, along with the anti-inflammatory result of sirolimus, but ‘disappearing’ over time as the vessel heals. R3 Vascular is headquartered in Mountain View, Calif., USA, with additional operations in Munich, Germany.

About RM Global Partners LLC

RM Global Partners is an investment banking and strategic advisory firm specializing in life sciences. Broker-dealer services are provided through Beech Hill Securities Inc., a FINRA/SIPC member.

PRESS RELEASE / 05.03.2020

Supira Medical, A Shifamed Portfolio Company, Closes $35M in Series B Financing

Company Appoints Seasoned Medtech Executive as President and CEO

CAMPBELL, Calif., March 5, 2020 – Supira Medical, formed by Shifamed as part of its medical innovation hub, announced today the closing of $35M in Series B financing. Officially closed on February 25, the financing was led by Cormorant Asset Management with participation from The Capital Partnership (TCP), 415 CAPITAL, AMED Ventures and Shifamed Angels. The funds will be used to advance product development and clinical efforts for the company’s next generation percutaneous ventricular assist device (pVAD). Additionally, the company announced the appointment of seasoned medical device executive, Dr. Nitin Salunke, as President and Chief Executive Officer.

“Supira’s innovative approach could potentially provide a meaningful clinical solution for patients requiring temporary mechanical support during coronary interventions,” stated Bihua Chen, Founder and Managing Member of Cormorant Asset Management. “Despite advances in PCI, a large unmet need exists for high-risk patients and we are excited to lead and further invest in Supira Medical.”

Percutaneous ventricular assist devices (pVADs) are used during stent placement or angioplasty to provide temporary mechanical support for patients with severe coronary artery disease or comorbidities. Additionally, pVADs are used to treat patients suffering from cardiogenic shock (CS), a condition that can occur following a severe heart attack, and is associated with a high rate of morbidity as a patient’s heart is suddenly too weak to adequately pump blood to vital organs.

“Temporary mechanical support provides many patients with the option to undergo coronary interventions that their heart would otherwise not be healthy enough to endure,” stated Nitin Salunke. “I am pleased to join the Supira team as we advance pVAD technology with a low-profile, high-flow solution that aims to improve outcomes for these high-risk patients.”

Nitin brings over two decades of medical device development and leadership experience to Supira Medical. Previously, he served as Vice President of Research and Development for Medtronic’s Neurovascular business and a member of its management board. In this role, Nitin was responsible for the strategic growth through new product development for the global business, which included therapies for treating ischemic and hemorrhagic strokes. Prior to Medtronic, Nitin served as the Vice President of Research and Development at Altura Medical (acquired by Lombard Medical), as well as Director of Research and Development Engineering at Cordis Corp, a Johnson and Johnson company (acquired by Cardinal Health). Early in his career, Nitin was with W.L. Gore & Associates, holding roles of increasing responsibility within new product development, engineering operations and marketing. Nitin is an inventor / co-author on several patents and publications. Nitin holds a PhD in Mechanical Engineering, with research focus in Cardiovascular Biomechanics, from the University of Maryland Baltimore County. Additionally, he holds an MS from the University of Oklahoma and an Executive MBA from San Jose State University.

“I am delighted to have Nitin join and lead Supira at this important time. His strong medical device experience and leadership skills make him an ideal fit to spearhead the company towards its first clinical milestone,” commented Amr Salahieh, Founder of Shifamed and Chairman of Supira Medical. “The closing of this significant financing round speaks to the large, unmet need Supira’s technology will address.”

About Supira Medical, Inc.

Supira Medical, a privately held portfolio company of Shifamed, is focused on development of a next generation percutaneous ventricular assist device (pVAD) for use in high-risk patients undergoing interventional procedures. To learn more about Supira Medical, please visit www.supiramedical.com.

About Shifamed, LLC.

Founded by serial entrepreneur Amr Salahieh, Shifamed is a highly specialized medical innovation hub focused on developing solutions that accelerate time to market, reduce risk, increase impact, and forge a path toward a world where patients are able to lead longer, healthier lives. To learn more about Shifamed, please visit www.shifamed.com.

DGAP-News: 415 Capital Management GmbH / 14.01.2020 / 16:04

415 CAPITAL Announces First Closing of New MedTech Venture Capital Fund

415 CAPITAL Management GmbH (415 CAPITAL) today announced that it has held a first closing of its new MedTech Venture Capital fund (415 CAPITAL Fund I). The  fund will invest in early and development-stage medical device companies in Europe, Israel and the UnitedStates with a strong focus on startups developing groundbreaking technologies to diagnose and treat cardiovascular disease and its associated risk factors, including coronary artery disease, structural heart disease, heart failure, stroke, hypertension and vascular disease. The fund will hold a final closing at up to €85 million later in 2020.


About Cardiovascular Disease:

Cardiovascular disease is the worldwide leading cause of death and the single largest cost driver in the global healthcare system. The disease causes one in three deaths each year and the World Health Organization projects the global economic burden of cardiovascular disease to exceed $1 trillion annually by 2030, fueled by several secular trends such as population ageing and growth and the global obesity epidemic.


About 415 CAPITAL:

415 CAPITAL has been formed by MedTech entrepreneurs and investors Frank Groenewegen, David Thompson and Frederik Groenewegen. The three founding partners share a 28-year history of introducing medical device technologies to the European market as well as making private investments in innovative MedTech companies. The team has funded 45 MedTech startups over the years, realizing over 25 exits to-date including ReBound Therapeutics (sold to Integra LifeSciences in 2019), Claret Medical (sold to Boston Scientific in 2018), ReCor Medical (sold to Otsuka Holdings in2018), ImThera Medical (sold to LivaNova in 2018), CardiAQ Valve Technologies(sold to Edwards Lifesciences in 2015), and CoreValve (sold to Medtronic in2009).

The new fund marks the first-time that the three partners are bringing in capital from outside investors to continue their strategy. First-closing investors include the EuropeanInvestment Fund (EIF), KfW Capital, several family offices and distinguished MedTech entrepreneurs. The founding partners have themselves committed over 20% of the current fund size.


Close Cooperation with European Physiciansand Clinical Sites:

In addition to providing MedTech startupswith early-stage funding, 415 CAPITAL offers its portfolio companies directaccess to the European healthcare market through a partnership with medicaldevice distributor CoRRect Medical GmbH (CoRRect). Led by MedTech engineer Michael Braun and supported by a designated team of clinical and regulatory specialists, CoRRect closely works with leading physicians across over 200 hospitals and clinical sites in the fields of cardiac surgery, cardiology, radiology and vascular surgery. Over the past two decades, the CoRRect team has commercialized dozens of groundbreaking medical device technologies, including the world’s first pre-crimped coronary stents, transcatheter aortic heart valve replacement(TAVR) and the world’s first stroke protection for left-heart interventions.

"The CoRRect team has been at the forefront of innovation in cardiovascular health for over two decades and we are very excited to start this new chapter in our partnership. We will continue to leverage our access to hospitals and physicians to accelerate the clinical and commercial adoption of our fund’s portfolio technologies in order to create value for patients, physicians and investors." – commented Frederik Groenewegen, Co-Founder and Managing Director of 415 CAPITAL

P+P Pöllath + Partners acted as legal and structuring advisor to 415 CAPITAL.

Horizon 2020, EFSI and 415 CAPITAL: 415CAPITAL Fund I GmbH & Co. KG is supported by InnovFin Equity with financialbacking of the European Union under the Horizon 2020 Financial Instruments and the European Fund for Strategic Investments (EFSI) set up under the Investment Plan for Europe. The purpose of EFSI is to help support financing and implementing productive investments in the European Union and to ensure increased access to financing.

European Investment FundEuropean Commission