SAN FRANCISCO – While the large companies naturally draw the close attention of analysts at the premier JPMorgan Healthcare Conference, the firms that often pique investor interest even more at this event are the smaller private companies receiving an invitation to pitch their wares – those wares often pointing to the leading edge developments evolving in med-tech.
One company likely to receive close investor attention in months to come is NovoCure (Haifa, Israel), a six-year-old company that has developed a truly novel cancer treatment modality.
The company’s NovoTTF (tumor treating field) device has been designed to disrupt cancer cell growth by creating an alternating electric field in the region of a tumor. According to company Chairman William Doyle, the electric field generated by the device exerts forces on dividing cancer cells that disrupt the mitotic process. Importantly, he noted that the electrical field created by the device has no effect on non-dividing cells.
The NovoTTF is a non-invasive device, consisting of four sets of insulated electrodes attached to an electronic box. The technician places the electrodes on the outside of the scalp. The electrodes generally resemble bandages with wires attached. The electrodes connect to a portable TTField-generating box running off a battery. The device is lightweight (about 6 lbs) and fits neatly into a dedicated carrying case that is provided to the patient.
When using the patient wears the device continuously for as long as their disease is stable or regressing. The company provides the patients with around the clock technical support. During the treatment the patient will be able to maintain normal daily activity.
The NovoTTF, Doyle said, has the potential to prevent cancer cells from starting mitosis and the potential to destroy cancer cells that enter the cytokinesis (hourglass) phase of mitosis. Preliminary study data has shown that the cancer tumor growth is slowed and may even reverse after continuous exposure to TTFields.
Doyle reported the system winning the CE mark, in December, for use in the treatment of recurrent and newly diagnosed glioblastoma multiforme (GBM), the most common form of brain cancer.
The company is “halfway through” its enrollment process (expected to be about 236 patients total) for an FDA Phase III trial for patients with recurrent GBM, which Doyle called a “large initial market opportunity.”
While GBM is the initial target, Doyle described the system as becoming a platform technology which, over time, could have “broad applicability to a full range of cancers.”
Said Doyle, “We’ve done extensive in vitro work including tests on 15 proliferating cell lines including human lung, breast, colon and prostate cancer [and we see the [therapy’s] effects on every one. Because this is physics and not chemistry, there’s no selectivity based on the cells. We’ve observed the destructive mechanisms in all of these cultures and importantly, the strength of the effect is strongest when the cell is aligned with the field direction.”
Doyle pointed out that this technology uses lower frequency levels of energy than the better known microwave therapies that are already out there. “We see no heating, no nerve or muscle stimulation and no radiation, so this is not just another way to cook a local cancer tumor.”
He also said that by itself, the therapy has not produced any noticeable side effects other than a few instances of skin irritation beneath the electrodes.
While the technology can be used as a standalone product, Doyle said its greatest promise appears to be as an adjunct with existing chemotherapies and biologic agents.
In a pilot study for GBM patients who received both TTF and chemotherapy had a two to three times increase in the median time to progression and about a four to five times increase in progression-free survival.
“We have eight of 10 patients alive, healthy and well approaching three and a half to four years for some patients.’
The company is also doing Phase II and III FDA clinical studies on breast, lung and newly-diagnosed GBM cancers.
SurgRx (Palo Alto, California), developer of the EnSeal system for surgical hemostasis, also made its pitch to a full room of attentive attendees.
Founded in 2001, SurgRX is the developer of an advanced vessel fusion system used in electrosurgical devices. The company’s Smart Electrode Technology is embedded in the EnSeal product family of electrosurgical devices.
The device consists of a radio frequency (RF) controller and disposable instruments, with this system enabling surgeons to seal and transect small-to-larger vessels, large pedicles and tissue bundles while achieving surgical hemostasis.
According to David Clapper, president/CEO of SurgRx, this is the only system that controls energy delivery at the electrode/tissue interface.
The device was developed by the same inventor who designed the NovaSure System from Novacept (Palo Alto, California) to treat menorrhagia. Novacept, which has largely the same management team as SurgRx, including Clapper, was sold to Cytyc (Boxborough, Massachusetts) for about $325 million in 2004 (Medical Device Daily, March 23, 2004).
“This device allows surgeons to essentially do bloodless surgery,” said Clapper. He reported that the annual revenue market for these types of devices is about $800 million annually, which includes competitors such as Ethicon Endosurgery (Cincinnati) Covidien (North Haven, Connecticut) and Gyrus (Southborough, Massachusetts).
Clapper pitched the company’s system as superior to the competition because it “clearly develops better seals.” He noted that there is “less bleeding with our device” and “less thermal damage” with the EnSeal, meaning the tissue left behind after a procedure.
He also said that the SurgRx system doesn’t give off smoke and the procedure leaves no scars behind.
Clapper said the devices are used in the fields of gynecology, urology, breast surgery and thyroid surgery every day.
Apparently investors like the team’s proven track record. They have poured more than $63 million into the six-year-old company to date.
It currently has about $11 million in debt.