Led · Seed · Apr 2018

S4 Medical develops the esolution catheter, a patented device intended to deviate and protect the esophagus during catheter ablation for atrial fibrillation. The company says the esolution device is compatible with electrophysiology systems and has completed first‑in‑human testing and secured intellectual property. S4 plans to use its Series A financing primarily to conduct an Investigational Device Exemption (IDE) study estimated to begin in July 2021 as it advances toward commercialization. The team includes cofounders Emile Daoud, MD (Chief Medical Officer and Electrophysiology Section Chief at The Ohio State University) and CEO William Fuller. Since its founding in late 2017, S4 has reported rapid progress on regulatory and technical milestones. The company positions the esolution catheter as a comprehensive solution to reduce esophageal complications during AF ablation. S4 Medical is a Columbus, Ohio-based medical device company developing the ESolution device to protect the esophagus from thermal damage during catheter ablation. ESolution is inserted through the mouth into the esophagus and uses a proprietary method to deviate the esophagus away from potential thermal injury. The company completed its first human studies in seven patients in Argentina. S4 Medical is led by co-inventor and co-founder Dr. Emile Daoud and co-founder and CEO William Fuller. The company recently secured additional, undisclosed funding to continue development of its device. Backers include investors such as the Ohio Innovation Fund and ProMedica. Sotera Medical Corp. is developing a novel medical device intended to protect the esophagus during catheter ablation procedures for atrial fibrillation. The company’s initial product is described as a simple, comprehensive solution aimed at reducing esophageal complications from ablation. Sotera’s founding team includes CEO and co-founder William Fuller and co-founder Dr. Emile Daoud, director of electrophysiology at The Ohio State University Wexner Medical Center. The company closed initial seed funding in excess of $1 million to accelerate technological development. Proceeds are intended to support further development and to advance toward first-in-human testing by late 2018. The team positions the device as addressing an important unmet need to improve patient safety and outcomes during AF treatment.

Participated · Equity · Jan 2017

O2 RegenTech is advancing OXAID™, a proprietary oxygenating wound dressing intended to enhance healing of chronic wounds by providing oxygen, moisture and bacterial protection. The company holds pending patents licensed from The University of Akron. Leadership is headed by Dr. Andreas Inmann, President & CEO. O2 RegenTech has been awarded grants to fund R&D, including an NSF SBIR and an NIH STTR. The company also received funding from the Ohio Third Frontier Technology Validation and Startup Fund. These awards support continued development and validation of the OXAID™ technology.

Led · Debt Financing · May 2012

SPR Therapeutics is a medical device company focused on providing non-opioid, minimally invasive pain treatments. Its core product, the SPRINT® PNS System, is a 60-day peripheral nerve stimulation therapy cleared for use up to 60 days and studied for low back, shoulder, post-amputation, and post-operative pain. The system is intended to recondition the central nervous system to deliver sustained pain relief without a permanent implant, nerve destruction, or risk of addiction. The device is indicated for symptomatic relief of chronic, intractable pain and various post-surgical and post-traumatic acute pains, but is not intended for cranial and facial nerve regions. Following an $85M financing (a $25M Series D-1 insider equity and a $60M debt facility), SPR plans to use proceeds to expand U.S. sales representation into additional territories and to support continued product development. The company is led by President, CEO and Founder Maria Bennett and is headquartered in Cleveland, OH with satellite offices in Chapel Hill, NC and Minneapolis, MN. SPR Therapeutics commercializes the FDA-cleared SPRINT® Peripheral Nerve Stimulation (PNS) System, a restorative 60-day treatment designed to provide significant and sustained pain relief without permanent implants, nerve destruction, or opioids. The SPRINT system is positioned for early use in the care continuum and has been studied for low back, shoulder, knee, post-operative, and post-amputation neuropathic pain. SPR says clinical trials and more than 30 peer-reviewed publications demonstrate improvements in pain, function, quality of life, and reduced opioid use. The company reports rapid commercial uptake — use more than doubled in the past year and the system has treated over 6,500 patients. SPR also holds over 200 issued and pending patents and emphasizes a large body of clinical evidence underpinning its offering. Headquartered in Cleveland, OH, with satellite offices in Chapel Hill, NC and Minneapolis, MN, SPR plans to expand commercial reach, support additional clinical research, and advance next-generation technology backed by new financing. SPR Therapeutics, based in Cleveland, Ohio, develops neurostimulation technologies for chronic and acute pain. Its FDA-cleared SPRINT® Peripheral Nerve Stimulation (PNS) system uses a threadlike wire placed through the skin connected to a wearable stimulator to activate target nerve fibers, offering a non-narcotic alternative without permanent implants or tissue destruction. The company plans to use the Series C proceeds to commercialize the SPRINT PNS system and to fund additional research across multiple indications, including post-surgical acute pain and chronic low back pain. SPR is led by founder, CEO and president Maria Bennett. The board recently added Nick Valeriani, an experienced healthcare leader who previously served as CEO of West Health and held executive roles at Johnson & Johnson. Prior to this round, SPR had approximately $10 million in prior equity financing and has received nearly $23 million in non-dilutive funding from the U.S. Department of Defense and the National Institutes of Health. SPR Therapeutics has developed a proprietary peripheral nerve stimulation technology platform aimed at treating acute and chronic joint pain and post-amputation pain. Its investigational SPR™ System positions electrodes in proximity to, but not directly contacting, peripheral nerves and is limited by U.S. law to investigational use. The platform includes two products: the SMARTPATCH™ system, intended for use up to 30 days, and the fully implantable MICROPULSE® system for long-term pain management if pain returns after Smartpatch therapy. The company plans to use new funding to commercialize its pain therapies built on this technology. SPR was founded in January 2010 as a portfolio company of NDI Medical, LLC and is led by President and CEO Maria Bennett. The company raised $5m in Series A financing to support those commercialization efforts. SPR Therapeutics makes a generator-based neurostimulation system that electrically stimulates a peripheral nerve to exercise a muscle and treat pain. The system is initially aimed at reducing shoulder pain in patients who have suffered strokes. Company leadership frames the device as a platform technology that could be applied to treat pain in multiple areas of the body. SPR has applied for the CE Mark and may receive European regulatory approval soon. Financially, SPR raised a $2.2 million Series A earlier in the year and has been approved for a $900,000 loan from the Ohio Department of Development to commercialize the technology and fund machinery, molds, tooling, and IP protection costs.

Led · Equity · Mar 2011

AxioMed develops a lateral viscoelastic disc replacement and is pursuing a multi-level cervical IDE. The company closed an oversubscribed first round of funding from surgeons and high-net-worth individuals and is launching a $10 million second round with pledges ahead of an October planned launch. AxioMed expects its first lateral disc to be used overseas and included in CE approval in Q1 2018 and aims to pursue aggressive overseas sales in 2018. The company is preparing to begin a multi-level cervical IDE in the U.S., anticipating an expedited cervical IDE approval and near-term U.S. availability. Leadership positions the product as the first truly viscoelastic disc in the U.S. upon FDA clearance and the most advanced viscoelastic disc OUS, citing competitor divestment from first-generation designs. Management also reports strong interest from global partners for distribution and inbound investor interest prior to the second round opening. AxioMed Spine is a Cleveland, Ohio-based spinal orthopedics company that develops products focused on spinal function for patients with degenerative spine disease. Its flagship Freedom® Lumbar and Cervical Discs were developed and designed by a team of clinicians and experts in biomechanics, pathology, spinal surgery and polymer science. Both devices have received CE Mark approval for distribution in the European Union. AxioMed is pursuing US regulatory approval for its Freedom technology. The company raised $3.6M in funding from existing and new investors. The company is led by President and Chief Executive Officer Patrick McBrayer and Chief Operating Officer James Kuras. AxioMed Spine Corporation develops spinal orthopedics products intended to restore spinal function for patients with degenerative spine disease, advancing the standard of care beyond fusion and first‑generation disc replacements. Its core products include the Freedom® Lumbar Disc (FLD) and the Freedom® Cervical Disc, both developed by a team of clinicians and experts in biomechanics, pathology, spinal surgery and polymer science. The FLD is on the market in the EU and is advancing toward completion of an IDE pivotal study in the US. The Freedom Cervical Disc recently received a CE Mark for introduction in the EU, and the company intends to follow a similar regulatory and marketing pathway for it as for the FLD. AxioMed completed the final closing of its Series D financing, raising $5 million in two tranches from current and new investors, augmenting a previously announced $15 million Series D. The company states its mission is to restore the natural function of the spine and to continue research, innovation, development and service worldwide. AxioMed Spine develops and manufactures artificial spinal disc replacements, including a CE‑marked lumbar disc and a second cervical disc product the company is preparing to launch. The company will use a $500,000 state loan to purchase machinery and equipment to manufacture the cervical discs at its Garfield Heights, Ohio plant, which is also its corporate headquarters. The loan was recommended by a group associated with the Ohio Department of Development and is pending approval from the State Controlling Board. AxioMed hopes to obtain CE Mark clearance to commercialize the cervical disc later this year; its lumbar replacement received CE Mark in 2009. The lumbar device is roughly two years away from U.S. regulatory review: AxioMed has enrolled about 300 of 350 patients in a pivotal study and expects to complete enrollment next quarter before a two‑year follow‑up to support a PMA application to the FDA. Since its 2001 inception the company has raised $56 million in financing and lists backers including CID Equity Partners, Early Stage Partners, Investor Growth Capital Limited, Primus Capital, Memphis Biomed Ventures, Reservoir Venture Partners and Thomas, McNerney & Partners. AxioMed Spine is developing next-generation Freedom lumbar and cervical spinal disc replacements made from a rubberized polymer and designed to restore natural spine function. The company won CE Marking in May, enabling sales across the European Union, and has introduced Freedom in Germany, Switzerland and the United Kingdom. AxioMed plans to use recent funding to continue product development and to expand operations, adding to a headquarters workforce of 15 people once its fundraising round is complete. AxioMed completed the first part of its third financing round, raising $6.4 million from unnamed leading venture capital firms and is working toward a Series C target of $18.5 million. Previously the company had raised $34 million from investors including CID Equity Partners, EarlyStage Partners, Investor Growth Capital Limited, Primus Capital, Memphis Biomed Ventures, Reservoir Venture Partners and Thomas, McNerney & Partners, and its most recent prior round was a $10 million fundraise in July 2008. The company's president and CEO is Patrick McBrayer and its headquarters are in Garfield Heights, Ohio.