Led · Equity · Jun 2019

Evofem Biosciences is a San Diego-based biopharmaceutical company developing women's sexual and reproductive health products. The company focuses on products for women's sexual and reproductive health. In 2019 it announced additional financing from PDL BioPharma. PDL provided $30M in April and a further $50M in June as part of an $80M financing package. The announcement indicates the company is actively securing capital to support its development efforts. No operating metrics or other financial details beyond the disclosed financing amounts are reported in the article. Evofem is a San Diego-based biotechnology firm focused on developing new contraceptives for the women's reproductive health market. The company is led by Saundra Pelletier. In August 2016 Evofem announced a $25M Series D financing. The funding came from Woodford Investment Management. Proceeds are designated for clinical and commercialization infrastructure and to support its current technology pipeline. The raise is intended to advance clinical work and build commercialization capabilities. EVOFEM, based in La Jolla, San Diego, CA, markets feminine hygiene products and is developing technologies in women’s reproductive health. Its lead drug candidate, Amphora, is being evaluated as a microbicide to protect women from pregnancy and sexually transmitted diseases, including HIV/AIDS. The company plans to use the new proceeds to accelerate commercialization of Amphora and to advance a program with Médecins Sans Frontières to distribute the product in Africa. Management highlighted the potential impact of the technology on the AIDS pandemic worldwide. The company also added Dr. Kenneth Herbst, former Deputy Surgeon General of the Army for Reserve Affairs and a UCSD professor of medicine, to its medical advisory board.

Participated · Debt Financing · Dec 2014

Direct Flow Medical is an emerging medical device company focused on the Direct Flow Medical Transcatheter Aortic Valve System, a metal-free valve that uses a polymer frame. The system is expanded with saline/contrast for assessment and repositioning, then locked in place with a quick-curing polymer; its double-ring design creates a tight seal and the valve is fully repositionable and retrievable up until polymer exchange. The low-profile, fully sheathed delivery system avoids rapid pacing and minimizes vascular complications and is commercially available in Europe for extreme-risk surgical patients. The company is progressing toward U.S. regulatory approval and is currently enrolling patients in the SALUS pivotal trial while pursuing expansion outside the U.S. Financially, Direct Flow Medical closed a $32 million financing to support the SALUS trial and international growth. The company has strengthened its commercial leadership with the appointment of Chris Richardson as Chief Commercial Officer and named Dan Rose Vice President and General Manager of EMEA to support global commercialization. Direct Flow Medical develops a transcatheter aortic valve implantation (TAVI) system designed with a metal-free frame and a low-profile, flexible delivery system intended to reduce aortic regurgitation. The company won CE Mark approval in the European Union for its flagship TAVI device and has closed a U.S. feasibility study. It has begun initial enrollment in its SALUS U.S. feasibility trial and hopes to proceed to a pivotal trial later this year. Direct Flow is positioning its relative newness as an advantage by addressing surgeon complaints about rival devices. The company faces competition from large medtech firms but is using recent regulatory and clinical milestones to support commercialization efforts. The new financing is intended to support those commercialization activities. Direct Flow Medical develops a catheter-based, percutaneous-delivered prosthetic aortic valve for transcatheter aortic valve replacement. The company is pursuing a Series C financing to fund business build-out in a large, fast-growing market sector. It has raised $40.0M to date toward a projected $42.5M Series C round. Wolverine Venture Fund announced its participation in the Series C; this marks WVF's second investment in the company, the first having occurred in 2005. Past and participating investors named in the articles include Johnson & Johnson Development Corp., Foundation Medical Partners, VantagePoint Venture Partners, ePlanet Ventures, EDF Ventures, New Leaf Venture Partners and Spray Venture Partners. The financing is intended to provide the critical funds the company needs to advance its business, according to WVF commentary. Direct Flow Medical is a Santa Rosa, Calif.-based startup developing heart implants. The company makes minimally invasive aortic-valve replacements for the heart. It raised $27 million in a second funding round. Investors in the round included Johnson & Johnson Development, Foundation Medical Partners, VantagePoint Venture Partners, ePlanet, EDF Ventures, New Leaf Venture Partners and Spray Venture Partners. The article notes the aortic-valve replacement field is booming. Competitors mentioned include JenaValve, AorTx and Sadra.

Led · Debt Financing · Oct 2013

LENSAR develops and commercializes the LENSAR Laser System, an intelligent laser platform for refractive laser-assisted cataract surgery (ReLACS). The system uses Augmented Reality technology to produce a 3-D model of the eye’s anterior anatomy for customized treatment and precise placement of laser pulses. Led by CEO Nick Curtis, the company is focused on commercializing the LENSAR Laser System across North America, Europe, Asia, Latin America and select markets worldwide. LENSAR intends to use recent financing to support long-term growth, continued commercialization, and development of its hardware- and software-driven platform. The company is based in Orlando, Florida. LensAR is an Orlando, Florida-based developer and supplier of laser and advanced 3D imaging technology for refractive cataract surgery. Its core product is the LensAR™ Laser System, a high-resolution imaging system that produces a high-contrast, low-noise image of the anterior eye in a single scan. The system enables actual correction of lens tilt and provides different centration options during treatment. The LensAR Laser System recently received FDA clearance. The company intends to use the $10M debt facility to commercialize the system. LensAR has treated more than 700 eyes outside the United States to date and is led by CEO Nick Curtis. LensAR develops next-generation laser systems and advanced 3D imaging technology for refractive cataract surgery. Its core product, the LensAR Laser System, pairs a mobile laser head and patient docking with proprietary 3D-CSI imaging to generate personalized surgical treatment plans. Clinical features include measurement of lens tilt and decentration, varied cataract fragmentation algorithms that reduce ultrasound energy, and an ergonomic footprint compatible with typical workflows and multiple operating room layouts. Previous generations of the system have FDA clearance for anterior capsulotomy and lens fragmentation, and the technology has been used in more than 600 eyes outside the United States. The company recently closed a $24 million private financing to support first commercial shipments in the United States, Europe and select markets worldwide and to fund ongoing R&D into additional clinical applications. Management changes announced with the financing include the appointment of Chief Commercial Officer Nick Curtis as interim CEO while former CEO Randy Frey remains on the board and will serve as a consultant. LensAR, Inc. develops and commercializes a next-generation laser system and advanced 3D imaging technology for refractive cataract surgery. The LensAR™ Laser System is FDA-cleared for anterior capsulotomy and lens fragmentation and has been used in more than 500 eyes outside the United States. Topcon Europe Medical BV has made an equity investment in LensAR and entered a long-term strategic cooperation that includes distribution and marketing of the LensAR Laser System in Europe. That cooperation was first announced on September 16, 2011, and the recent announcement ahead of ESCRS in Vienna generated several indication-of-interest deposits toward future delivery upon European commercialization by Topcon. Topcon framed the move as a commitment to technologies that enhance patient outcomes and to integrating LensAR's system with its ocular surgery, implants and diagnostics portfolio. LensAR described the ESCRS reception and the Topcon investment as an endorsement and a commitment to integration and success of the technology in partner physician practices.

Led · Debt Financing · Apr 2013

Avinger develops therapeutic devices that incorporate intravascular imaging and the lumivascular approach to treating vascular disease. Its product portfolio includes Ocelot, commercially available since late 2012 to open totally occluded arteries, and Pantheris, a lumivascular atherectomy system that has received CE Mark approval. The company reports its products have helped physicians treat more than 15,000 patients suffering from PAD. Founded in 2007 and based in Redwood City, Calif., Avinger is preparing to begin enrollment in the U.S. VISION trial for Pantheris. Management said it closed a significant funding round with participation from both new and existing investors to support the anticipated clinical trial. The financing was accompanied by three new board additions — James Muzzy, John Delfino and Donald A. Lucas — intended to add strategic management experience. Avinger develops and markets lumivascular interventional devices that integrate light‑based, radiation‑free intravascular imaging into catheters to give physicians live, video‑rate images during arterial treatment. Its commercially available products include the Ocelot family and Lightbox, and it is developing Pantheris™, a next‑generation lumivascular atherectomy device. The company reports its global product portfolio has helped physicians treat more than 13,000 patients with peripheral artery disease. Founded in 2007 by Dr. John B. Simpson and based in Redwood City, Calif., Avinger positions lumivascular technology as a way to improve vascular disease treatment and reduce invasive surgery and amputations. The company used the financing to support continued commercialization of existing products and further development of Pantheris. The article does not disclose revenue figures. Avinger develops catheter-based medical devices that integrate intravascular Optical Coherence Tomography (OCT) to treat peripheral artery disease (PAD). Its product portfolio includes the Ocelot real-time OCT crossing catheter—which is CE marked and commercially available in Europe—and the Wildcat and Kittycat catheters; the company reports its products have helped treat more than 10,000 patients. Avinger is also developing Wolverine, described as the first peripheral atherectomy catheter to incorporate intravascular imaging using OCT. The company plans to invest the new funds to accelerate worldwide sales of existing product lines and to continue R&D and clinical trials for additional intravascular-imaging products. Avinger expects to submit a 510(k) to the FDA for Ocelot later this year. The company highlights the clinical need—PAD impacts 8 to 12 million U.S. adults and contributes to roughly 150,000 leg amputations annually. Avinger was founded in 2007 by Dr. John B. Simpson and is based in Redwood City, Calif. Avinger develops next-generation catheter-based technologies for the treatment of peripheral artery disease (PAD), leveraging intravascular Optical Coherence Tomography (OCT). Its marketed products include the Wildcat and Kittycat catheters and Ocelot, the first real-time OCT crossing catheter. Ocelot received the CE Mark in September 2011 and early EU commercial cases are reported to show remarkable patient outcomes. The company says its global product portfolio has helped physicians treat more than 5,000 patients with PAD. Avinger is focused on developing additional therapeutic devices that incorporate OCT and plans to further U.S. and EU commercialization of Wildcat, Kittycat and Ocelot. It recently closed a financing round to support commercialization and continued technology development. Avinger develops next‑generation catheter-based technologies that merge intravascular imaging and therapeutic capability to treat peripheral artery disease. The company markets the Wildcat and Kittycat guide wire support catheters and is completing development of therapeutic catheters that integrate real‑time OCT imaging. Its pipeline includes the Ocelot catheter, which completed a first‑in‑man feasibility trial in Poland in August 2010, and the Wolverine image‑guided atherectomy catheter. Avinger is completing enrollment in its CONNECT study seeking a more specific FDA indication for the Wildcat device, with enrollment expected to finish in Q1 2011. The company was founded in 2007 and is based in Redwood City, California. A recent $25 million financing will be used to accelerate commercialization and further development of its imaging and therapeutic catheter technologies.

Led · Equity · Oct 2012

AxoGen develops and commercializes products used in surgical repair of peripheral nerve injuries, based on a University of Florida‑licensed enzyme treatment that enables regeneration of donated nerves. The company was co‑founded in 2002 and has more than 50 employees in Alachua. Prior to going public in 2011 it reported its products were used in roughly 400 hospitals and thousands of surgeries, including treatment for injured soldiers. AxoGen reported $4.9 million in revenue in 2011 and a record $2.01 million in Q2 2012, reflecting strong year‑over‑year growth. Management says the company will use new proceeds to expand its sales force, increase physician outreach, and develop new peripheral nerve products.