• EndoGastric Solutions

  Participated · Series G · May 2014

  EndoGastric Solutions is a Redmond, Washington–based medical device company focused on incisionless surgical technologies for GERD, notably the EsophyX device and the TIF 2.0 procedure. The company positions TIF 2.0 as a safe and effective alternative to surgery, citing more than 140 peer‑reviewed publications and outcomes showing many patients can eliminate daily medications for up to five years. Over 35,000 TIF 2.0 procedures have been performed worldwide, and EGS emphasizes an exemplary safety profile. EGS closed an $18M financing to further drive growth and broaden commercialization of the TIF 2.0 procedure. The financing announcement coincided with a leadership transition: Darin Hammers was appointed President and CEO, replacing Skip Baldino, who will remain a strategic advisor. Management says the new capital will provide added fuel to accelerate the company’s commercial evolution and adoption among physician partners and patients. EndoGastric Solutions develops a minimally invasive treatment for gastroesophageal reflux disease (GERD) using its TIF 2.0 procedure and a proprietary device that corrects the root cause of reflux without surgery. The company reports having performed the procedure on 22,000 patients to date. It aims to expand the reach of its non‑surgical option to capture a larger portion of the GERD market. Financially, EndoGastric recently closed a $45M Series I financing and has raised about $251M since launching in 2003. Company leadership says the new capital establishes a strong financial foundation to pursue significant growth and long‑term commercial viability. EndoGastric Solutions develops and commercializes innovative, evidence-based, incisionless procedural therapy for gastroesophageal reflux disease (GERD). Its core offering is the TIF® procedure, which the company is commercializing to physician customers. The company plans to use new financing to continue commercial expansion of the TIF® procedure and to support its physician customer base. It also intends to invest in sustaining engineering initiatives aimed at optimizing gross margin. The company is led by President and CEO Skip Baldino. GERD is a chronic condition in which the gastroesophageal valve allows gastric contents to reflux into the esophagus, causing heartburn and potential injury to the esophageal lining. EndoGastric Solutions (EGS) is a Redmond, Washington–based medical device company focused on incisionless treatment of GERD via its Transoral Incisionless Fundoplication (TIF) procedure and EsophyX devices. The company markets EsophyX technology—cleared by the FDA in 2007 and updated with the EsophyX Z in 2015—to reconstruct the gastroesophageal valve and reduce reflux. EGS reports more than 17,000 TIF patients treated worldwide since clearance and cites over 50 peer‑review papers documenting outcomes on more than 800 unique study patients. Recent changes in coding and payment—CPT Code 43210 and APC 5331 for TIF procedures effective January 1, 2016—aim to improve patient access and reimbursement. EGS says it will use new financing to begin broad‑scale commercialization and to fund R&D on next‑generation products used in the TIF procedure. The company positions TIF as a minimally invasive alternative that can reduce long‑term PPI use for chronic GERD sufferers. EndoGastric Solutions develops products and procedures that combine gastroenterology and surgery to address unmet needs in gastrointestinal diseases. Its core product, the EsophyX device, was FDA cleared in 2007 and is commercially available in the United States. The EsophyX device is inserted transorally with visual guidance from an endoscope and is used in the TIF procedure to reconstruct the gastroesophageal valve, restoring its competency and reestablishing the barrier to reflux. The company, led by President and CEO Skip Baldino, intends to use newly raised funds to support publishing data from three randomized trials, bring new products to market, and establish clear reimbursement for its technology. Financially, the company completed a $30M Series G financing to support these plans. The article does not disclose operating metrics such as revenue or user counts.

• Lanx

  Participated · Series C · May 2013

  Lanx is a Broomfield, CO-based global spine company that develops and commercializes a line of fusion devices and minimally invasive technologies. The company closed a $15M Series C equity financing to support growth. It plans to use the funds to increase its sales and marketing infrastructure and to expand its product suite across both minimally invasive and core spinal fusion. Led by CEO Dan Gladney, Lanx’s platform includes minimally invasive technologies and a range of fusion solutions. Product examples cited include the TIMBERLINE™ Lateral Fusion System and the ASPEN® MIS Fusion System. Lanx distributes its portfolio throughout the U.S., Mexico and Europe via a network of direct sales representatives and exclusive distributor partners.

• Mitralign

  Participated · Series D · May 2012

  Mitralign develops direct transcatheter mitral and tricuspid valve repair systems, including the Trialign System and the Mitralign Percutaneous Annuloplasty System (MPAS). MPAS received CE mark approval in February for the treatment of functional mitral regurgitation (FMR). The Trialign System is currently enrolling patients in an early feasibility IDE study in the US and is not approved for sale or distribution. With $39.8 million raised to date in a Series E equity financing, the company plans to pursue US and CE regulatory approval for Trialign while preparing for commercial launch of MPAS in Europe. The funding will be used to accelerate clinical trials in both the United States and Europe and to expand the company’s tricuspid clinical data set. Mitralign is a venture-backed medical innovation company located near Boston, Massachusetts. Mitralign makes the Mitralign System, a catheter-delivered device that deploys pairs of anchors which are cinched together to restore the mitral valve's shape in patients with functional mitral regurgitation. The company completed enrollment of 61 FMR patients in a European clinical trial and is collecting follow-up data for a CE Mark submission. Management said it will continue to enroll patients in active clinical studies to accrue additional data for the medical community. Mitralign expects to report results from the trial before the end of 2014. Financially, the Tewksbury, Mass.-based company raised about $8.1 million in a recent equity round and previously closed a $35 million Series D in May 2012. Mitralign has developed a catheter-based, percutaneous direct annuloplasty system intended to repair functional mitral regurgitation by reducing mitral annulus size and bringing leaflets closer together. The system delivers a pair of surgical implants into the mitral annulus via catheter; the implants are cinched and can be customized in location, extent of cinching, and number to suit patient anatomy. The company is conducting clinical studies to evaluate the technology for first-line percutaneous and trans-apical treatment of FMR and is completing a CE Mark study. Proceeds from the financing will support completing the CE Mark study, securing the CE Mark, and initiating sales in the EU. The press release cites a large addressable market, noting more than 2.5 million people in the U.S. with moderate or severe FMR and an expectation from an investor that a PMVR market could exceed $1 billion. Mitralign was founded by the Accelerated Technologies (ATI) medical device incubator and is based in Tewksbury, Massachusetts. Mitralign develops a catheter-based mitral valve repair device intended to treat mitral regurgitation in patients with congestive heart failure. The company is advancing development of its mitral valve repair technology and is using external financing to support operations. Mitralign secured a $5m senior secured credit facility to provide working capital as it progresses device development. The financing was provided by GE Capital, Healthcare Financial Services. Leadership emphasized the lender's industry expertise and fit with the company's needs. The company is based in Tewksbury, Massachusetts.

• Aptus Endosystems

  Participated · Equity · Jan 2009

  Aptus Endosystems is a privately held Sunnyvale, Calif. medical device company focused on developing advanced technology for endovascular aneurysm repair (EVAR). Its products include the HeliFX Aortic Securement System, which is cleared by the U.S. FDA and bears a CE Mark, and the Fortevo AAA Endograft System, which has a CE Mark and is investigational in the United States. The company has developed a unique endograft and helical anchor technology intended to enable minimally invasive EVAR while providing control and potential long-term durability. Proceeds from the financing will be used to expand commercialization of HeliFX in the United States and Europe, develop additional HeliFX product offerings, execute a U.S. clinical trial of the Fortevo system to support a Premarket Approval filing with the FDA, and expand Fortevo utilization in key European centers. Management stated the capital will be used judiciously to grow product use, introduce new aortic repair products, and approach profitability. Aptus Endosystems is a Sunnyvale, Calif. biotech company developing the Abdominal Aortic Aneurysm Repair System, a device designed to fix abdominal aneurysms. The company is using the funding to finish clinical trials of the repair system. Management says the $30 million round should cover a U.S. launch in 2010 and a smaller release in Europe. Aptus previously raised $19.5 million in 2006 to advance the device through early trial phases. The company’s near-term plans center on completing trials and bringing the product to market in the U.S. and Europe. Financially, the new third-round financing is positioned to support those commercialization milestones.

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