Pelvalon Receives FDA Approval for the Eclipse System

Five years of hard work has paid off for the team at Pelvalon.  Last year the FDA had designated the company’s de novo application a Priority Review and today the team received word that FDA has approved the device.  Women suffering from loss of bowel control now have a viable, safe solution to their debilitating condition.  Congratulations to the Pelvalon team!

Vaxess Wins $1 Million Verizon Powerful Answers Award

Congratulations to the Vaxess team for winning the prestigious Verizon start-up award!  The team took home the top prize in the transportation category for their plans to create a soluble, silk-stabilized vaccine that can be shipped without refrigeration, and extend the global reach and access to vaccine products.

Two from Vaxess make Top Lists

Vaxess Technologies co-founder Livio Valenti and CTO Farshad Guirakhoo recently received awards highlighting their commitment to changing the world of vaccines.  Livio was named to Forbes’ 30 Under 30 for Science & Healthcare.  Farshad was named by VaccineNation to its annual list of the 50 Most Influential People in Vaccines.  Congratulations to both Livio and Farshad!

Svelte Medical Hits All Endpoints

The results for DIRECT II, a clinical trial testing Svelte Medical’s new approach to stenting, was reported in conjunction with TCT.  The Integrated Delivery System the company developed for coronary stent placement was being tested in Europe.  The trial hit all of its clinical endpoints, including reduced procedure time.  It’s always nice to highlight technologies that can provide great care while simultaneously reducing the needs of the overall healthcare system.

Pelvalon Announces Pivotal Trial Results

Pelvalon made its clinical debut at AUGS today with some truly amazing results.  The team has worked incredibly hard over the past four years to developed a new treatment paradigm for one of the most debilitating conditions, fecal incontinence.  The PI of the study summarized it best: “This trial heralds a new era of treatment opportunity for women with bowel control problems.”  Hats off to everyone at Pelvalon!

Daktari Awarded NIH SBIR for HCV

The NIH has awarded Daktari with a grant to develop a point-of-care hepatitis C diagnostic system.  Hepatitis C has emerged as a major global pandemic, affecting nearly 175 million people worldwide.  This grant enables the company to develop new diagnostic tests beyond its initial focus on HIV care.  The grant was part of the NIH SBIR Fast Track program.

Aaron is a Finalist for NEVY Award

Yesterday the New England Venture Capital Association announced the finalists for the 2014 NEVY Awards.  Norwich’s Aaron Sandoski was named a Rising Star VC finalist.  We’re excited that Aaron has been nominated and are honored to be part of such a thriving entrepreneurial community.  The winner will be announced the night of May 14th during the NEVY awards party.  Good luck to Aaron and the other nominees from Polaris, Atlas, Google, and Third Rock.

We Have Moved

In conjunction with raising our latest fund, we decided to make a few adjustments at the firm.  The most obvious is a move to Cambridge.  In the past few years, we have seen a shift in where Boston area MedTech entrepreneurs build their companies.  Historically Route 128 has dominated.  But recently there has been a significant shift towards Cambridge.  We too have shifted our location, having moved to the Alewife area of Cambridge.  So far it has proven to be the happy middle ground between the suburbs and the city.

Aimed at Increasing Vaccine Access, Vaxess Raises the First Part of a $3.75M Series A

By Lauren Landry, BostInno

After taking home $25,000 in Harvard Business School’s 2012 New Venture Competition, Vaxess Technologies went on to win another $70,000 from Harvard’s inaugural President’s Challenge. Within a year, the team was securing another $50,000 through Harvard Business School’s alumni business plan competition and, Thursday, have even more news to unveil.

Vaxess has closed the first tranche of a $3.75 million Series A financing, led by Norwich Ventures. Angel investor Jeffrey Walker also participated in the round for an undisclosed amount.

The Boston-based company uses silk-derived proteins to stabilize vaccines without refrigeration, eliminating the need for cold-chain transport. To date, 98 percent of vaccines have to be stored between 35 and 46 degrees Fahrenheit. In low-income, rural areas, however, there isn’t an infrastructure for cold storage, making the task nearly impossible.

That was, before Vaxess.

“The medical community has a long history with silk-based products in patient care,” said Norwich Ventures Aaron Sandoski, who will be joining the company’s board of directors, in a release. “Norwich Ventures is excited to be working with the Vaxess team to dramatically improve the availability of vaccines around the world.”

Vaxess reports they will use this round of funding to “enhance internal product development capabilities, advance silk-stabilized products through preclinical development and continue collaborations with pharmaceutical and global health partners.”

The team’s technology originated in the labs of biomedical engineering professors David Kaplan and Fiorenzo Omenetto. Vaxess’ founding team rallied around the duo’s work in a Commercializing Science class while at Harvard and, four months later, the company was born.

“Vaxess’ proprietary technology offers vaccine manufacturers a unique opportunity to improve product stability, thereby enabling lower distribution costs, increased global access and reduced waste,” said Vaxess CEO Michael Schrader in a release.

After seeing how far Vaxess has come in the last year, only bigger headlines are expected for the year to come.

Daktari Diagnostics Collects $7M in Funding

By Patricia Resende, Boston Business Journal

Daktari Diagnostics Inc. has landed another round of funding. The Cambridge, Mass.-based developer of diagnostic tests for HIV, hepatitis and tuberculosis secured $7 million in equity financing, according to documents filed with the U.S. Securities and Exchange Commission.

In addition to Bill Rodriguez, co-founder and CEO, listed as directors in the filing are Aaron Sandoski, managing director at Norwich Ventures; Roger Kitterman, a partner at the Partners Innovation Fund and a co- founder of Mass Medical Angels; Edward Roberts, professor at the MIT Sloan School of Management; Stanley Lapidus, CEO of SynapDx Corp.; David Rubin, principal in Merck’s Global Healthcare Innovation fund; and Christopher Earl, president of Innotrove, LLC.

The latest round of funding comes just one month after Daktari said it will expand into Scotland and hire 126 new employees. The company said it will enter that region with its HIV blood monitoring technology, a battery-powered CD4 white blood cell counter used in monitoring HIV patients that will marketed for use in developing and emerging countries.

Before this last round of funding, Daktari received a $5 million tranche of a planned $10 million financing round announced in December 2011. That financing was led by Merck & Co. Inc. (NYSE: MRK) venture capital arm, Merck Global Health Innovation Fund, which was joined by the company previous investor group, led by Norwich Ventures and the Partners Innovation Fund. Previous backers of Daktari have also included, Launchpad Venture Group, Hub Angels Investment Group and Boston Harbor Angels. In August 2011, Daktari landed $1.25 million in debt financing.

Daktari was co-founded in 2008 by Rodriguez, former chief medical officer of the William J. Clinton Foundation, and Mehmet Toner, a professor of engineering at Harvard and MIT. Requests for comment were not returned before deadline.

Social Entrepreneurship and MedTech

BBC News recently published an online article titled, “Small firms which want to profit from doing good.”  The article highlights the growing trend of social entrepreneurship and how great entrepreneurs are creating new business models to bring profitable solutions to the billions at the bottom of the pyramid.  MedTech plays a central role in social entrepreneurship since finding solutions to disease and the economic burden of poor health are critical in order for countries to thrive.  We were delighted to see one of Norwich’s portfolio companies as the article’s leading case example.

Here is a link to the article:

Norwich Ventures Leads Series A Round of Podimetrics

Norwich Ventures recently led the first financing of Podimetrics, a Cambridge, Mass-based company dedicated to developing innovative systems to keep diabetic feet healthy.  The company has strong Boston roots having been founded by a group of MIT and Harvard graduate students who met at H@cking Medicine, and later incubated by Rock Health in Boston.  We are excited to be supporting the next phase of the company’s growth.

Boston Scientific Acquires Rhythmia Medical for up to $265 Million

Norwich portfolio company Rhythmia Medical was acquired yesterday by Boston Scientific (NASDAQ: BSX). As with any acquisition of a portfolio company, it is a bittersweet moment. We invested in the founders, Leon Amariglio and Doron Harlev, six years ago and have been able to see them take an exciting idea and turn it into an industry-changing technology. It’s wonderful to see them realize a significant outcome for their passion, risk and hard work (the sweet part). Unfortunately, it also means our time working with the company and watching it grow has to come to an end (the bitter part). We wish the best for Boston Scientific as they build out their electrophysiology business.

You can read the press release at

Stent Development Company Initiating Clinical Trial Raises $8M

By Stephanie Baum

A stent development company founded by serial entrepreneurs Robert Fischell and his sons David and Tim, has brought in $8 million in new investment for its second generation stent for cardiac surgery, raising about $25 million in debt and equity since December, according to Form D filings with the Securities and Exchange Commission.

The additional investment will go towards initiating clinical trials for the second generation of its Acrobat stent in New Zealand, Europe and South America this year.

In an interview with MedCity News, Mark Pomeranz, the CEO of Svelte Medical Systems, said the drug-eluting stent creates a low thrombogenic surface to reduce the possibility of blood clots. Its coating is designed to dissolve as the drug is delivered, lowering the chances of an inflammatory reaction from the coating. The original Acrobat stent received CE mark approval in Europe in 2010.

Svelte is conducting a 30-patient clinical trial of its drug-eluting stent in New Zealand, a favorite for cardiology trials because its country-wide approval process is quicker and easier from a regulatory perspective.

Pomeranz, a veteran of Johnson & Johnson (NYSE:JNJ) company Cordis Cardiology, acknowledged that it has been a challenging climate to raise money for medical device companies as venture capital firms move away from investing in the sector due to the pace of the FDA and the new healthcare tax. Additionally, with more revenue coming from overseas, more businesses are moving activities offshore and repatriation taxes are reducing the likelihood of their return, he said. The industry is facing a new era.

Despite setting itself up to compete with the likes of Medtronic (NYSE:MDT), Abbott Laboratories (NYSE: ABT) and Boston Scientific (NYSE:BSX), Pomeranz sees an opportunity to carve a niche for itself.

The global stent market for the heart is estimated at $5 billion and the stent market for peripheral arteries, an area the company plans to move into, is about $500 million.

“The nice thing in the U.S. market is that even though there are 1,000 catheterization labs, 200 of them drive 60 percent of volume in the market,” said Pomeranz. “That means you don’t need a large sales force to be very effective. When you’re looking at a $5 billion market, even 10 percent to 15 percent of that is very nice.”

QIAGEN Acquires Intelligent Bio-Systems to Enter Next-Generation Sequencing Market

Yesterday it was announced that a Norwich portfolio company, Intelligent Bio-Systems, was acquired by QIAGEN (NASDAQ: QGEN). Using the technology developed by Intelligent Bio-Systems, QIAGEN plans to enter the next-generation sequencing market. It’s an exciting opportunity and we wish them great success.

You can read the press release at

Entrepreneur Magazine Names Boston a Winner in Business Travel Awards

As a MedTech investor we have become used to software companies receiving all the limelight.  Gaming and social media companies are talked about endlessly as fun and cool places to work. When Entrepreneur magazine recently named Boston as the winner of the 2012 Business Travel Awards, we were not surprised. There are many great restaurants and hotels that have become part of the entrepreneurial ethos of the city. What did surprise us was that the article highlighted three “visible” companies, and none of them were software – Zipcar, Daktari Diagnostics and Preserve. We are delighted that the excitement around Daktari‘s global mission is shared by others.

Here is a link to the article:

Circulation Publishes Study Highlighting the Performance of Rhythmia Medical’s Mapping Catheter

BURLINGTON, MA – Rhythmia Medical Inc., highlights the publication of results from a feasibility study of the Rhythmia Mapping System in Circulation Arrhythmia and Electrophysiology.

The article, “Rapid, High-Resolution Electroanatomical Mapping: Evaluation of a New System in a Canine Atrial Linear Lesion Model”, was authored by Drs. Warren Jackman, Hiroshi Nakagawa and their colleagues at the Heart Rhythm Institute at Oklahoma University. The article highlights the advanced capabilities of the system to “accurately and quickly identify geometry and complex patterns of activation in the canine right atrium with little or no manual annotation of activation time”.

“We are very pleased with the results of this evaluation and other studies that demonstrate the advances of our Electrophysiology 3D Mapping and Navigation System” noted Doron Harlev, Co-Chief Executive Officer of Rhythmia Medical, Inc. “We look forward to continuing to advance our development, clinical and regulatory efforts with this very promising technology platform.”

The article can be accessed through:

Cardiac arrhythmia affects more than 7.5 million people in the United States and Europe, and is a life-threatening condition that can lead to stroke or heart failure. Catheter ablation procedures, currently performed at a rate of over 500,000 per year, represent a greater than $2 billion market with one of the fastest growth rates in medical devices.

About Rhythmia Medical

Founded in 2004, Rhythmia Medical, Inc. is developing a next generation Mapping, Visualization and Navigation system for the treatment of cardiac arrhythmias. The company is conducting human clinical testing outside the US and is working with several of the leading clinicians in this field around the world. The Burlington, Massachusetts based company has raised financing from a number of investors, including corporate, private and leading medical device venture capital firm Norwich Ventures. The Company has been awarded ISO 13485 certification. Additional information can be found at

Merck Leads $10M Funding of HIV Diagnostics Firm Daktari

By Arlene Weintraub, Xconomy

Cambridge, MA-based Daktari Diagnostics announced in late December that it has raised $10 million in financing from a syndicate of private and venture firms. The funding round was led by Merck Global Health Innovation Fund, a unit of Whitehouse Station, NJ-based Merck (NYSE: MRK). Also participating in this funding round were Daktari’s existing investors, Norwich Ventures and the Partners Innovation Fund.

Daktari’s technology can analyze small quantities of blood and other fluids. The company developed a cell-counting system that’s portable and doesn’t require the lenses, cameras, or filters commonly used in other diagnostics systems. The company says it will use the recent funding to market its first products, which are designed to monitor patients with HIV.

Merck Global Health Innovation Fund was founded in 2010. According to its website, the $250 million fund fosters startups in six key areas, including health informatics and analytics, heath intervention, and “health productivity enablers.”