Led · Equity · Jun 2014

Spinal Kinetics designs and manufactures the M6-C cervical and M6-L lumbar artificial discs, which replicate the anatomic structure and biomechanics of a natural disc by incorporating both an artificial nucleus and annulus. The M6 technology was introduced internationally in 2006, is available in over 27 countries, and has approximately 30,000 implants to date. The company completed an FDA‑approved pilot study in the U.S. and has received FDA approval to initiate a larger clinical trial comparing single‑level cervical disc replacement to single‑level fusion, with enrollment already underway at multiple U.S. spine centers. Spinal Kinetics plans to use recent financing to initiate the U.S. FDA clinical trial for the M6‑C and to expand international commercialization and clinical programs. The company also announced a global settlement of patent litigation with Synthes and DePuy Synthes, with terms confidential. Founded in 2003 and based in Sunnyvale, California, Spinal Kinetics focuses on developing innovative and practical solutions for treatment of spinal disease.

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.

Participated · Series D · Mar 2013

Avedro is a Waltham, MA–based ophthalmic pharmaceutical and medical device company led by CEO Reza Zadno, PhD. The company has developed a patented corneal cross-linking technology that includes drug formulations and medical devices, which is approved for sale in numerous countries. Avedro is developing proprietary corneal remodeling products to treat keratoconus, corneal ectasia and to provide refractive correction as an alternative to contacts and eyeglasses. It secured $25M in financing to support its programs. The company plans to use the funds for product development, clinical studies and commercial efforts, including expansion of sales and reimbursement support. Avedro’s board gained Hongbo Lu, PhD, as a representative of the lead investor in connection with the financing. Avedro develops and commercializes corneal cross-linking pharmaceutical and device therapies, including FDA‑approved Photrexa Viscous, Photrexa and the KXL System. The company sells additional capital equipment and formulations outside the U.S., such as UV‑X devices, the KXL and Mosaic Systems, and VibeX and MedioCROSS. Avedro announced a combined $42 million equity and debt financing to support commercial expansion and pipeline and clinical development programs. It has opened a new manufacturing facility in Burlington, Massachusetts, near its Waltham headquarters, to increase production capacity and support a global supply chain. The facility employs 5S, Lean and Six Sigma methodologies and will accommodate an anticipated year‑over‑year increase in large capital equipment production in 2017. Avedro is also expanding its corporate team to support growth and broader commercialization efforts. Avedro develops corneal cross-linking platforms and related pharmaceuticals, including the KXL and Mosaic systems and formulations such as VibeX and MedioCROSS. Its Mosaic System performs the PiXL procedure, intended to deliver non-surgical correction of myopia and improve cataract surgery outcomes. The company distributes products outside the United States through a network of ophthalmic medical device distributors; its products are not approved for sale in the United States. Avedro has re-submitted an NDA to the U.S. FDA for its corneal cross-linking technology and anticipates a PDUFA action date in April 2016. Proceeds from recent financing are intended to strengthen the balance sheet, expand global distribution of KXL, commence commercialization of Mosaic outside the U.S., and support potential U.S. commercialization if FDA approval is received. The company describes its work as advancing the science and technology of corneal cross-linking and refractive correction. Avedro develops corneal crosslinking capital equipment and related pharmaceutical (riboflavin) products used to treat multiple corneal pathologies and to improve LASIK outcomes via its Lasik Xtra procedure. The company’s products have received CE Mark and have been commercially launched in 32 countries outside the United States; Avedro’s products are not for sale in the U.S. It reports that nearly 50,000 Lasik Xtra procedures were performed worldwide in 2012. Avedro is preparing to launch a new device platform that it says will open significant new procedure opportunities previously demonstrated in early trials. Its technology is being evaluated in three Phase III clinical studies in the U.S. involving more than 100 sites. The company plans to pursue U.S. FDA approval and expand applications of corneal crosslinking into cataract and refractive surgery. Avedro is a privately held ophthalmic device and pharmaceutical company based in Waltham, MA developing systems and procedures to biomechanically strengthen and modify the cornea. The company produces and sells the KXL System for performing Lasik Xtra and Accelerated Cross-linking and the Vedera System for performing Keraflex, an incisionless thermal procedure to flatten the cornea. Both devices are CE Marked and commercially available outside the United States. Avedro positions KXL as a way to enhance the LASIK market by offering patients added security and Vedera as able to induce refractive change without removing tissue. The company completed a $25 million Series C and plans to use the proceeds to expand commercial operations of the Vedera and KXL Systems outside the United States and to seek U.S. FDA clearance.

Participated · Series C · Jun 2012

Astute Medical is a San Diego-based diagnostics company that developed NephroCheck, a biomarker test for acute kidney injury (AKI). Last month the company won 510(k) clearance from the FDA for NephroCheck, which is used to test for AKI in patients following serious cardiac or respiratory events. NephroCheck will be marketed by Ortho-Clinical Diagnostics. Astute is positioned to receive up to $30 million under a standing loan agreement with funding partner CRG to commercialize NephroCheck, plus an additional $10 million if it hits certain revenue milestones. Its most recent disclosed financing prior to this was a $40.4 million Series C in 2012 led by MPM Capital and the venture arms of Johnson & Johnson and Kaiser Permanente. The company indicated plans to have representatives at the 2014 CVT Critical Care conference in Washington. Astute Medical, based in San Diego, develops novel biomarker-based medical diagnostics. The company is led by CEO Christopher Hibberd. It focuses on rapid diagnosis and risk assessment for community- and hospital-acquired acute conditions, including abdominal pain, acute coronary syndromes, cerebrovascular injury, kidney injury and sepsis. The company plans to begin commercializing its first product and to advance and expand research, development and validation of biomarker-based laboratory tests. The recent financing is intended to fund those commercialization and R&D efforts. Astute Medical is a San Diego company dedicated to identifying and validating protein biomarkers as the basis for novel diagnostic laboratory tests. Its core work centers on biomarker discovery, research, development and clinical validation for rapid diagnosis and risk assessment. The company focuses on community- and hospital-acquired acute conditions, with current areas of interest that include abdominal pain, acute coronary syndromes, cerebrovascular injury, kidney injury and sepsis. In August 2011 it completed a $13M financing as an extension of its Series B round. The transaction involved the sale of additional Series B shares to existing stockholders, and the proceeds are intended to advance and expand its R&D and validation efforts. No operating metrics (revenue/users) were reported in the article. Astute Medical is a San Diego, California–based developer of novel, biomarker-based medical diagnostics focused on protein biomarkers. The company aims to identify and validate protein biomarkers to commercialize high‑potential diagnostic products. Current areas of interest include abdominal pain, acute coronary syndromes, cerebrovascular injury, kidney injury and sepsis. Management says it will use new capital to advance research and development and to conduct clinical studies that move products closer to commercialization. Astute Medical was founded in 2007 and is led by Christopher Hibberd and Paul McPherson, Ph.D., who were formerly members of management at Biosite Incorporated. The company completed a Series B to support these development and clinical efforts.

Participated · Equity · Apr 2012

WaveTec Vision is an Aliso Viejo, California–based company that introduced a diagnostic device for cataract surgery. The company is commercializing the ORA System, which uses Optiwave™ technology with a new light source and optics to perform intraoperative wavefront aberrometry at a higher level of performance. The ORA System is designed to enable surgeons to optimize outcomes for their cataract patients. Led by president and CEO Tom Frinzi, WaveTec is focused on expanding commercial efforts and refining its product. The company recently secured financing to support those commercialization and product-refinement plans.