SAN FRANCISCO – While larger companies at the J.P. Morgan Healthcare Conference have their fans, it is the smaller private companies that really pique the interest of many investors with their potential for developing dynamic new products and, hopefully, to get in on a good thing early.
Following is a sampling of some interesting newcomers who presented at this week's conference.
AccessClosure (Mountain View, California), a company founded in 2002 to develop a vascular closure product for use during interventional and diagnostic procedures, was pitched by its president and CEO, Fred Khosravi.
The company's lead product, the Mynx vascular closure device, was approved by the FDA in May 2007 and since then, has been used in more than 150,000 patients. The device achieves femoral artery hemostasis via extravascular delivery of polyethylene glycol (PEG), a biomaterial commonly used in medical devices and pharmaceutical products.
Khosravi described how the product works. The water-soluable PEG mix sealant is delivered to the targeted area via a 6 Fr or 7 Fr procedural sheath. Temporary hemostasis is achieved by introducing an inter-arterial balloon, followed immediately by the mix sealant.
The non-thrombogenic sealant then instantly absorbs blood and subcutaneous fluid, rapidly expanding up to three to four times its original size inside the tissue tract and producing a durable hemostasis. The sealant dissolves within about 30 days, leaving nothing behind but a healed artery.
Since the product was approved by the FDA 18 months ago, Khosravi said that Mynx already has achieved a 12% market share in the vascular closure market. He also noted that the device is sold at an average 25% premium to existing closure devices. Khosravi attributed the product's success to a key metric that he said differentiates it from any other product on the market – that it "is 99.9% free of any major vascular complications."
Over the next 18 months, Khosravi said the company plans to introduce a 5 Fr product for use in diagnostic procedures. He said the smaller size will allow the company to further penetrate into the manual compression market.
Developing a sort of GPS system for the lungs is superDimension (Minneapolis). Its inReach system provides electromagnetic navigation and guidance to distant regions of the lungs in a minimally-invasive manner, and is designed to enable doctors to diagnose lung cancer at earlier stages and potentially provide treatment sooner.
President/CEO Daniel Sullivan called the inReach a platform technology that will allow physicians to diagnose benign and malignant lung lesions as well as mediastinal lymph nodes at much earlier stages, enabling for much early treatment decisions for a condition that has traditionally been a death sentence if detected too late.
Sullivan projected that the lung cancer market alone is close to a $7 billion opportunity. More than 1.3 million people die of lung cancer each year around the world. It is the most common cancer-related death in American men and the second most common in women, claiming more lives than breast cancer, prostate cancer and colorectal cancer combined.
He said that the detection of lung cancer at early stages when a lesion is still the size of a pencil head is critical. At that stage "if you can get to it to biopsy it and if you can get to it to treat it, your long-term survival is 90% at 10 years." However, he noted that once the cancer has metastasized to golf ball-sized dimensions, a patient's long-term survival rate plunges to "15% in five years. It's a huge swing."
The inReach provides a substantial advantage over current procedures that are used for diagnosis of lung cancer which include the introduction of a transthoracic needle that has a 30% to 50% chance of collapsing a lung.
The other option involves taking out a wedge of lung tissue via an open chest surgical procedure. The only option that has thus far been palatable up to now for a majority of patients is what is known in the healthcare field as "watchful waiting," representing the patients that inReach is seeking to reach.
After a patient is diagnosed, the system can tag a lesion for radiation treatment or inject a dye to make the lesion easier to spot for surgery and the company is currently working with some other partners to add drug delivery and cryotherapy options to the arsenal of treatment options it can provide a patient.
"inReach assists physicians in reaching distant locations in the lungs, helping patients avoid more invasive procedures for diagnosing cancer," said Sullivan. "Many years ago, the angiogram transformed cardiac care because for the first time doctors could diagnose and treat the heart without opening the chest. We believe inReach can have the same dramatic effect on the pulmonology field, providing an option for patients with lesions that previously were unreachable."
Sullivan said the capital component for the inReach, which was cleared for marketing in the U.S. in 2007 (Medical Device Daily, Sept. 10, 2007), costs about $150,000 and the disposable component sells for about $1,000.
Looking to develop a bioabsorbable coronary stent is REVA Medical (San Diego), whose Chairman Bob Stockman said his company has finally emerged from a 10-year odyssey in its quest to perfect the stent geometry.
Sullivan noted that in the earliest days of stent design, the big companies involved in the space had sought to design absorbable stents but they were handicapped by both the materials available to them at the time as well as the geometries of the stents, which he characterized as "too thick and stubby," which prevented a practical root for stenting an artery open.
More recent efforts to develop bioabsorbable stents have so far met with limited success, he said, mainly because the stent fails to provide adequate support for the vessel over an adequate period of time, as exemplified by the first version of the Absorbable Metal Stent (AMS) from Biotronik (Berlin).
When researchers at REVA first decided to create a degradable stent, they already had the design in hand. They had recently developed a metal stent with a novel "slide and lock" design, in which the stent unfolds in the artery like an extension ladder instead of bending and expanding outward like most other stents.
The second challenge was finding the right material for the absorbable stent. Researchers at Rutgers University (Camden, New Jersey) helped the company develop a stent that is comprised of a tyrosine-derived polycarbonate material that has strength, flexibility, recoil and X-ray visibility equivalent to that of metal. A paclitaxel-eluting version also is in development.
As opposed to metallic drug-coated stents, Stockman said REVA's product addresses concerns regarding incomplete healing and late-stage thrombosis in patients, as well as reducing the need for long-term anti-platelet medication.
REVA, which commenced first-in-man trials in June 2007 (the RESORB trial), has established a broad strategic relationship with Boston Scientific (Natick, Massachusetts).