By Grant Welker
LOWELL -- For breast-cancer patients having a lumpectomy, there can often be a setback that follows even the successful removal of a tumor.
In one out of four instances, a patient needs a second operation to remove potentially harmful cells that surround the tumor but were not removed.
Innoblative, a startup connected to UMass Lowell's Massachusetts Medical Device Development Center, hopes that a new product it's developing will be able to quickly and easily remove those potentially cancerous cells using what's called radio-frequency ablation.
Innoblative won first place this spring in the 5th annual M2D2 $100k Challenge, which recognizes and rewards medical-technology and biotechnology startups.
It hopes to reach the market before the end of 2017.
"We're on the path to commercialization," said Chief Technology Officer Bob Rioux, during in an interview at the M2D2 Innovation Lab at the 110 Canal building in the Hamilton Canal District.
Innoblative has progressed quickly since the fall of 2013, when it was incorporated as a product envisioned by a group of Northwestern University students. Its first investor was Hadley-based VentureWell, foreshadowing what would become the company's reliance on Massachusetts workers and firms to get its product to market.
Tyler Wanke, an Innoblative co-founder and now its chief executive officer, said by phone from Chicago that founders saw an unmet need in the market, with no direct competitor in the works.
It's a large enough market that Innoblative estimates a potential for $500 million in sales in the United States.
Chicago has an "exciting medical-device scene," Wanke said, but the company turned to the Boston area for the specialized expertise it needed.
That's how Wanke came to hire Rioux, a Braintree native and Northeastern University graduate; and Ryan Bean, a Fitchburg native who has bachelor's and master's engineering degrees from UMass Lowell.
Innoblative is looking to rent M2D2 lab space to take advantage of an area designed specifically for medical devices like the as-yet-unnamed product Innoblative is developing.
"This is a great lab space compared to other start-up space we've seen," said Bean, who lives in Westminster.
The company is otherwise working out of a lab in Mansfield called Proven Process, which is helping Innoblative develop and manufacture the product -- a handheld device that uses radio-frequency waves, along with a saline solution, to kill potentially harmful cells within what is typically 1 centimeter of its edge. The process avoids costly, dangerous and time-consuming radiation, the company says.
Innoblative has so far tested the product on human and animal tissue, and expects to soon be able to test on breast tissue immediately after it's removed during a mastectomy. It plans to submit for Food and Drug Administration approval in about a year.
The product would be used immediately following a lumpectomy, while the patient is still under general anesthesia. The process would otherwise give only "a sensation of heat," Rioux said.
For now, Innoblative is focusing on breast-cancer cases. But in the long term, the company believes it can move beyond cancer uses and into other cauterization, such as to stop bleeding or prevent wounds from being infected.
Innoblative, which has also won competitions in Chicago and elsewhere, was one of five M2D2 companies to be awarded among 88 who applied. The others:
- LaunchPad Medical. LaunchPad's product, Tetranite, is unlike some graft procedures that require a secondary surgery to harvest bone from the patient, or others that take bone from cadavers or animals, the company says.
Tetranite uses a material called tetracalcium phosphate, or TTCP, which it describes as a "synthetic ceramic material." The product is still in early stages of development but has more than five years of feasibility and evaluation under its belt.
The company estimates the bone-graft market will hit $2.5 billion by 2020.
- Biorasis. The Glucowizzard allows a diabetic patient to check his or her glucose levels without a painful finger prick. The sensor is the size of a grain of rice, and is implanted just below the skin by the wrist. The sensor is wirelessly connected to a wearable device that looks just like a wristwatch.
The Glucowizzard, expected to hit the market in 2019, will find itself in a diabetes market expected to rise rapidly in the coming years.
- Kohana. As much as many health experts extol the benefits of breastfeeding, it can be a difficult and painful experience for mothers. Kohana said it has a product that is 30 percent to 50 percent more efficient in extracting milk, while being quiet and easy to use.
Kohana's product, called the Gala Pump, is a discreet hands-free device that uses a vacuum-like technology. It is expected to cost about $15 for a manual version and $80 for a compressor version, both well below what Kohana says its competitors cost.
- Disease Diagnostic. The company's product, Rapid Assessment of Malaria, or RAM, is just as it sounds. Malaria affects half of the world's population and kills 1 million people a year, according to Disease Diagnostic, which gives RAM a huge opportunity.
The portable handheld device uses magnets to study blood for markers that indicate malaria or other diseases. The entire diagnosis period takes only one minute.
The M2D2 winners received in-kind legal services from the firm Mintz Levin and from the competition's sponsors -- including Becton Dickinson and Boston Scientific -- equaling $100,000.
Each product still requires FDA approval but is considered Class 2, or needing somewhat less scrutiny than some other products.
Stephen McCarthy, co-director of M2D2, which is run jointly by UMass Lowell and the UMass Medical School, touted the role the center can have in such startups.
"I think these companies are going to stay here when they grow," he said.