Participated · Series C · Mar 2024

Shape Memory Medical develops proprietary shape memory polymers and devices for endovascular markets. Its low-density, porous embolic polymer is crimped for catheter delivery and self-expands on contact with blood to form organized thrombus, offering vascular space-filling, radiolucency, low radial force, and stimulation of healing. Commercial products include the TrelliX embolic coil and the IMPEDE and IMPEDE-FX Embolization Plug families; the IMPEDE and IMPEDE-FX plugs are approved in multiple jurisdictions and the IMPEDE-FX RapidFill is an investigational device. The company reports devices approved in more than 25 countries, CE marking for certain products, and PMDA approval in Japan for the IMPEDE plugs; U.S. indications for IMPEDE products are specified and IMPEDE-FX RapidFill is currently limited to investigational use. The FDA has granted an IDE to begin a prospective, multicenter, randomized trial to assess IMPEDE-FX RapidFill with EVAR. Shape Memory Medical recently completed a $38 million Series C to support the pivotal AAA-SHAPE trial, further R&D, and expansion of sales and marketing. Shape Memory Medical develops polymer embolization devices, including IMPEDE peripheral and TrelliX neurovascular products, based on proprietary shape memory polymer technologies. The polymers are licensed from Lawrence Livermore National Laboratory and Texas A&M University. The company holds access to 45 issued and pending patents covering basic polymers and specific clinical uses. Proceeds from the recent financing will be used to accelerate regulatory, clinical, and commercialization activities for its peripheral and neurovascular product programs. Its IMPEDE and TrelliX products have not been approved or cleared by the FDA and are not commercially available. The company is based in Santa Clara, California.

Participated · Series B · Feb 2022

Standard Bariatrics focuses on the development and commercialization of medical devices for bariatric surgery, led by CEO Peter Donato. Its flagship product, the Titan SGS surgical stapler, was cleared by the U.S. FDA on April 28, 2021 and meets the Class II product regulations for surgical staplers. The company works closely with bariatric surgeons to design and release solutions intended to address the global obesity epidemic. Standard Bariatrics plans to use new financing to accelerate commercial efforts for the Titan SGS and related proprietary devices. The business is based in Cincinnati, Ohio and has received multiple rounds of investor support. Standard Bariatrics develops the Titan SGS, a surgical stapler cleared by the FDA in April 2021 for sleeve gastrectomy procedures. The Titan SGS offers real-time audio and visual feedback and a 23-centimeter continuous staple cutline in a single firing. Clinical research cited by the company found faster stapling with fewer leaks and less bleeding versus other staplers. The device began a commercial launch in August supported by an initial tranche of funding, and was used in more than 1,000 procedures with positive physician feedback. Sales surpassed $1 million by November and have since risen to approximately $3 million, and the device was used in the first reported robotic sleeve gastrectomy shortly after launch. The company is using the newly completed financing to continue the commercial rollout and scale adoption. Standard Bariatrics is a Cincinnati-based medical device company and the first commercial spin-out from the Thompson Center at UCRI, founded by Dr. Jonathan Thompson. It has developed an FDA-cleared, reusable device to help surgeons standardize sleeve gastrectomy. The device is currently being used by selected doctors at the University of Cincinnati for a market valuation. The company plans to use its seed funding to generate intellectual property, launch its first products, and prove concepts for future products. Leadership includes Russ Holscher as President and CEO. Financially, Standard Bariatrics closed a seed funding round with Queen City Angels; the amount of the deal was not disclosed.

Participated · Series E · Aug 2020

Fractyl Health is developing Revita DMR, an outpatient endoscopic procedure that resurfaces the duodenal mucosa to treat insulin resistance and metabolic disease. Revita DMR has been studied in close to 300 patients and has received FDA Breakthrough Device Designation for T2D patients treated with insulin, as well as a CE mark in the EU. In the U.S. the device is not yet authorized for marketing and is being evaluated under an FDA-approved Investigational Device Exemption study. The company says its discoveries could address other metabolic diseases such as NAFLD/NASH and aim to reduce the global healthcare and economic burden of metabolic disease. Proceeds from the recent financing will support initiation of multiple late-stage clinical studies and accelerate ongoing REVITA-T2Di work to establish Revita DMR as a cornerstone therapy and reduce insulin dependence. Fractyl is based in Lexington, Mass., and recently renamed itself Fractyl Health to reflect its broader mission. Fractyl Laboratories is developing Revita DMR, a same-day, outpatient endoscopic procedure that uses heat to resurface the duodenal mucosa to reset metabolic pathways and address insulin resistance. Clinical data from close to 300 patients at more than 20 centers across three continents have shown durable improvements in type 2 diabetes and fatty liver disease and a favorable safety profile with no long-term adverse events reported. The Revita DMR System received a CE mark in April 2016 and the CE label was expanded in March 2020 to include insulin withdrawal, improvements in NAFLD/NASH in patients with T2D, and improved insulin sensitivity in PCOS. In the United States, Revita is approved for investigational use only by the FDA. Fractyl announced a first close of $55 million in a Series E financing; proceeds will support the Revita T2Di pivotal clinical trial examining glycemic control and insulin requirements, with a primary endpoint of percentage of patients achieving HbA1c ≤7% without insulin at 24 weeks versus sham. The company plans to initiate its pivotal U.S. trial later this year and use the financing to advance its regulatory and development activities for metabolic disease indications. Fractyl Labs develops Revita Duodenal Mucosal Resurfacing (DMR), an outpatient procedure intended to rejuvenate the duodenum and improve insulin sensitivity in people with type 2 diabetes. The company reports that a one-time Revita DMR treatment yields insulin-sensitizing effects and durable improvements in hepatic and glycemic indices over a year without intensive lifestyle changes. Fractyl plans to use the new funding to continue development of its Revita DMR technology and to support an ongoing Revita-2 multi-center clinical study, which began enrolling patients in Europe in May. Last year the Revita DMR System received a CE mark in the European Union. The company aims to submit an investigational device application with the U.S. Food and Drug Administration to enable investigational use in the United States. Fractyl recently raised $44 million in a Series D financing from multiple venture firms to advance these efforts. Fractyl Laboratories develops the Revita Duodenal Mucosal Resurfacing (DMR) system, a same-day, minimally invasive procedure intended to improve metabolic health in patients with type 2 diabetes. The approach is based on bariatric surgery procedures and aims to produce meaningful improvements in blood sugar and potentially reduce the need for additional medications. The company reported results from a 39-patient, single-site proof-of-concept study showing significant, beneficial changes in blood sugar and has treated 28 patients in its first international multicenter clinical trial. A multicenter Revita-1 trial is currently underway in Europe and South America, and Fractyl plans to begin randomized studies next year. Fractyl recently completed a $57M Series C extension to support and accelerate its clinical development and path to market. The company is headquartered in Waltham, MA, and its Revita system remains for investigational use only while trials continue. Fractyl Labs is developing Revita DMR, a non-invasive duodenal mucosal resurfacing procedure intended to alter the inner surface of the duodenum to change how the body absorbs sugar. The company says the procedure can potentially delay the need for insulin injections in patients with type 2 diabetes. Fractyl reported positive clinical data from a single-site study in Santiago, Chile showing a greater than two percentage-point drop in hemoglobin A1C at three months in 19 of 30 patients, with those 19 maintaining the same blood sugar level at six months. The effectiveness appeared dose-dependent: shorter treated segments produced smaller benefits. Fractyl is preparing to launch a multinational study by the end of 2014 and expects to start U.S. clinical development in 2016. The company is based in Waltham, Massachusetts, and is led by CEO and founder Dr. Harith Rajagopalan.

Participated · Series C · May 2020

Arterys is a San Francisco, CA-based global medical imaging platform that delivers clinical AI products over the internet. Led by co-founder and acting CEO John Axerio-Cilies, the company provides a web-based, AI-powered, FDA-cleared cloud-native viewer and platform. It operates a marketplace and ecosystem of partners to develop and deliver clinical applications built on its platform. The company raised $28m in a Series C to broaden that ecosystem and accelerate partner efforts. Arterys plans to extend its proprietary technology to application partners to make it easier for clinicians to integrate AI into their workflows from a single interface. The company emphasizes accelerating partners’ efforts to bring new clinical-grade AI applications to providers through its platform. Arterys is a San Francisco-based provider of a web-based AI platform for medical image analytics that enables physicians to process patient imaging cases with embedded AI algorithms. The cloud platform supports MRI and CT and offers image interpretation, case sharing, and automated reporting. Its proprietary technology protects patient information and complies with U.S. and EU data privacy regulations. Arterys' Cardiac MRI suite was the first product of its kind to obtain FDA clearance for use as a diagnostic support tool and is also cleared in Canada and the EU. The platform and cardiac MRI suite have been used to help diagnose more than 15,000 patients worldwide. The company plans to use the new funding to expand its web-based AI platform, launch oncology and neurology products, and accelerate commercialization of its cardiac offering. Arterys develops deep-learning diagnostic software for medical imaging that connects to standard MRI machines to enable non-invasive, precise quantitation of blood flow. The cloud-based platform uploads 10-minute chest MRI scans to a HIPAA-compliant server for computation and presents results in a web browser for clinician interaction and rapid approval of quantitative analyses. The solution targets cardiovascular applications including structural heart disease, congenital heart disease, carotid/neurovascular and renal vascular disease. The company plans to expand commercial operations for its visualization and quantification algorithm using proceeds from its recent Series A. The platform has regulatory clearances—CE Mark and U.S. FDA market clearance (March 2014)—and is already used for research at leading hospitals in the U.S. and Europe. Arterys anticipates broader distribution through ViosWorks in up to 7,000 GE MRI machines in H2 2016; the company is led by founder and CEO Fabien Beckers.

Participated · Equity · Aug 2019

EBR Systems is a Sunnyvale, Calif.-based developer of the WiSE (Wireless Stimulation Endocardially) wireless cardiac pacing technology designed to eliminate the need for cardiac pacing leads. Its initial product aims to remove the need for coronary sinus leads to stimulate the left ventricle in heart failure patients who require cardiac resynchronization therapy (CRT). The company plans future products to address wireless endocardial stimulation for bradycardia and other non-cardiac indications. EBR is conducting the SOLVE CRT multi-center, randomized, double-blinded, prospective international study to assess safety and efficacy of WiSE in support of a U.S. FDA premarket approval (PMA) application. The SOLVE CRT study is enrolling 350 heart failure patients who have failed to respond to, or cannot receive, conventional CRT and was expected to complete enrollment in 2020. EBR intends to use the recently raised funds to complete SOLVE CRT enrollment and to prepare for commercialization of the WiSE CRT System. Leadership noted in the article includes President and CEO John McCutcheon and Executive Chairman Allan Will (former Chairman and CEO). EBR Systems develops the WiSE (Wireless Stimulation Endocardially) wireless cardiac pacing system that implants a tiny electrode directly in the left ventricle to pace heart failure patients who have failed or cannot receive conventional CRT. The system aims to eliminate the need for coronary sinus leads and their associated complications by providing endocardial pacing via a rice-grain-sized implant. The company raised $50 million to conduct the SOLVE-CRT pivotal trial intended to establish safety and efficacy in support of U.S. Food and Drug Administration approval. Separately, EBR received CE Mark approval for its second-generation wireless transmitter, which is half the size of the first-generation device, extends battery life and enables a simpler, less-invasive implantation; initial cases were performed at four European clinical centers. Future products are planned to address wireless endocardial stimulation for bradycardia and other non-cardiac indications. The company's wireless pacing system is not currently available for commercial sale in the United States. EBR Systems is a Sunnyvale, CA-based developer of a wireless cardiac pacing system designed to eliminate the need for cardiac pacing leads. Its initial product eliminates the need for coronary sinus leads to stimulate the left ventricle in heart failure patients requiring CRT. Future product plans include wireless endocardial stimulation for bradycardia and applications in other non-cardiac indications. The company’s system is not yet available for commercial sale and is subject to obtaining a CE mark for Europe and U.S. IDE approval for clinical study. Led by Chairman and CEO Allan Will, EBR intends to use the recent funding for clinical studies and regulatory filings and has commitments toward a second-quarter closing. EBR Systems develops a new-style pacemaker and other cardiac pacing devices. The company raised a $35 million third round of financing to advance its product toward clinical trials. Delphi Ventures led the round, with existing investors De Novo Ventures, Frazier Healthcare Ventures, Split Rock Partners and SV Life Sciences participating. The Sunnyvale, Calif.-based company had previously raised $27 million across its first two rounds. The new capital is intended to support clinical testing and regulatory steps for its pacing device.