Medical Device Daily Senior

These days acquisition is the most likely exit strategy for most med-tech startups. The challenging financial environment has made it so that the words initial public offering are something of the past for most of this industry.

But there are a few smaller companies out there that have bigger visions than just developing a technology with the hopes of being bought out by a company with deeper pockets. One such company is NinePoint Medical (Cambridge, Massachusetts). NinePoint is developing a suite of optical imaging devices based on its optical frequency domain imaging (OFDI), a next-generation frequency domain optical coherence tomography (OCT) technology for use initially in the gastrointestinal tract. Ultimately the company hopes to build out the OFDI platform for use in a variety of areas beyond the GI tract.

“We're creating a company, not just developing a technology that will be acquired by someone else . . . we're building a company that can execute this platform,“ Charles Carignan, MD, president/CEO of NinePoint told Medical Device Daily.

NinePoint is a Third Rock Ventures portfolio company born to bring together access, diagnostics and treatment, Carignan explained. He said the OFDI technology that NinePoint is developing is a realization of that vision. Earlier this year, the company raised $33 million in a Series A funding round from Third Rock Ventures and Prospect Venture Partners.

Earlier this week the company reported an intellectual property (IP) licensing agreement it has made with Massachusetts General Hospital (MGH; Boston) for certain exclusive rights in multiple fields to 188 patents and patent applications owned by MGH. It is the largest IP agreement for medical device technology in the hospital's history as well as one of the largest IP agreements overall for MGH. The company said the patents and patent applications will support its high resolution optical imaging platform based on a next-generation OCT technology (Medical Device Daily, Dec. 14, 2010).

“Exclusive access to MGH's broad and deep portfolio of imaging patents is a significant milestone for NinePoint and we are honored that MGH has chosen to partner with us on the development of this important technology,“ Carignan said. “We believe our technology development roadmap will support the commercialization of novel medical devices that can significantly streamline the time and cost required to access, diagnose and facilitate treatment of pre-cancerous and cancerous cells. We are excited to be a pioneer in this convergence that we believe will positively impact patient care.“

Carignan told MDD the main significance of the recent agreement for NinePoint is the scope and breadth of the IP portfolio. “It gives us a very broad freedom to operate in protection in the OCT space . . . that's probably the reason it's so large and for us that's exciting.“

NinePoint's new suite of products is initially being developed to enable gastroenterologists and off site pathologists to review advanced tissue images during biopsies and other therapeutic and diagnostic procedures, in real time. This capability would potentially provide physicians with immediately actionable information and eventually, the ability to treat questionable cells at the time of diagnosis, according to the company. By streamlining the time line and the steps required to go from diagnosis to treatment, NinePoint believes it can significantly improve patient experiences and outcomes, improve the efficiency of care and provide important savings to the healthcare system. Over time, the company believes that the technology will have broad applicability across a number of diagnostic and therapeutic categories.

OFDI is a form of frequency domain optical coherence tomography (FD-OCT). Based upon exclusive access to this technology in its licensed fields, NinePoint believes it has the opportunity to create a family of devices that can dramatically improve patient care.

“Previous generations of OCT technology produced precise, but small images with long image acquisition times that rendered them unfeasible for clinical use. For the first time, technology exists that can open the door to utilizing real-time images for immediate diagnosis and treatment,“ said Brett Bouma, PhD, of the Wellman Center for Photomedicine at MGH and co-developer of the OFDI platform.

Carignan said the company is currently focused on developing devices, based on the technology, for gastroesophageal reflux disease (GERD) and Barrett's esophagus. The device will use infrared laser light to create a three-dimensional image of the esophagus, including areas beneath the surface that may be potentially cancerous. The technology allows the clinician to see deeper into the tissue.

To describe how this technology will be different - better - than current imaging technology, he compared it to taking a picture of a building.

“Think about looking through a camera at a building,“ Carignan says. “You can see the wall, the outline of the building, but you can't see through the wall to the inside. With our technology, you'll be able to see inside the building, past the wall.“

The technology will allow clinicians to see more areas of suspicion, he said. Ultimately it would allow the gastroenterologist to move directly into the treatment phase in the same procedure rather than having to take a biopsy, wait for the results, and then bring the patient back in for another procedure, he said.

“It's a lot of anxiety for patients waiting for pathology results, so we can eliminate that anxiety, speed (up the treatment) and eliminate costs.“

The next potential therapeutic areas for the technology include imaging the duodenum for celiac disease, the stomach for gastric cancer, the biliary tract for various cancers, and the pancreas, Carignan said. He said the colon is a possibility eventually as well as it may help GI doctors examining patients with irritable bowel disease better identify areas that need to be biopsied. Traditionally this is difficult in IBD patients because their bowel tissue is so inflamed it's not easy to tell what areas are suspicious.

The technology may also help with the monitoring of drug response for patients with ulcerative colitis or crohn's disease because it will allow the physician to see if the medication is working or not.

While NinePoint is initially focused on the GI tract, its technology and expertise will allow the company to expand into other indications in the future.

“Outside of GI we plan to do work in pulmonary imaging. We may be able to look at pulmonary lesions and nodules that maybe aren't identified on CT,“ Carignan said. Other possible applications he mentioned include monitoring treatment response for bladder cancer, a “number of applications“ in the gynecological tract, as well as in ENT. Also, he said, “we can image solid tumors so we'll start some work in a few years looking at breast tumors and seeing what we can do potentially in the breast as well.“

NinePoint says it will work closely with MGH to advance the development of the technology and the company plans to introduce the first device prototypes for use in clinical trials in 2011.

“It really is a large platform and that's what has us excited; it's about that potential and the number of diseases we could impact with this,“ Carignan said. “It's an exciting time both with the licensing agreement we just announced but also with the team we're creating here, we're recruiting a lot of top talents.“

Amanda Pedersen, 309-351-7774;

amanda.pedersen@ahcmedia.com

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