The word “realignment” usually indicates bad news.
But realignment can also be a bad news/good news kind of story, according to Vasomedical (Westbury, New York), which says recent staff reductions will help it preserve resources for movement into a broader, more profitable market – in this case, congestive heart failure (CHF).
Vasomedical is the developer of enhanced external counterpulsation therapy (EECP) technology, the basis for a system that uses a number of large blood pressure-type cuffs that are placed around portions of the body, with air then pumped through them to assist in improving blood flow and the heart’s pumping action.
Thomas Glover, the company’s president and CEO, said that Vasomedical has so far focused “on the angina marketplace, and the company has been very successful there.”
The company has sold 800 systems in the U.S., he told Medical Device Daily, and “now, we’ve got an opportunity to focus on CHF.”
The company yesterday reported that it has reduced staff and will make other budget tightening efforts in a “realignment” initiative that it estimates will save up to $3 million annually.
The staff cuts have already been made, Glover told MDD, but he said the company is not yet prepared to state the number involved. It would do so “in the near term,” he added.
“We now want to place resources appropriately,” he said, with more focused targeting of the CHF market.
After already having a clearance for treatment of angina since 1997, Vasomedical received FDA clearance of its EECP system for CHF in mid-2002 (MDD, June 18, 2002), and at the time it put the potential market at 10-fold that of the angina treatment opportunity.
But other critical steps were necessary over the past three years before marketing to the CHF segment could be launched, Glover said.
Those steps included upgrades of the EECP system (MDD, Nov. 10, 2004) and, certainly more importantly, the rollout of results from its Prospective Evaluation of EECP in Congestive Heart Failure (PEECH) study at this year’s meeting of the American College of Cardiology (Bethesda, Maryland) (MDD, March 11, 2005).
Those results indicated that EECP therapy was significantly more effective in improving a patient’s exercise duration than optimal pharmacologic therapy alone. After six months, exercise time increased by 25 seconds in the EECP group and decreased by 10 seconds in the control group. Additional endpoints of symptom status, assessed by New York Heart Association functional class, improved 31% in the EECP group compared to 16% in the control group.
Additionally, overall quality of life, as reported on the Minnesota Living with Heart Failure scale, also improved significantly among patients treated with EECP therapy.
The company also has established an EECP patient registry at the University of Pittsburgh Graduate School of Public Health to track patient improvement using EECP. Glover said that the registry now includes data on 7,000 patients, with 2,000 of them suffering from CHF.
These efforts and the restructuring just unveiled thus lay the ground for aggressive market focus on CHF, which offers a total patient pool of 5 million in the U.S. and 550,000 newly diagnosed cases of CHF each year. This compares to the angina market where, the company has said, an individual physician may not see enough angina patients to rationalize the investment in an EECP system of upwards of $150,000.
All of these initiatives thus provide “opportunities we feel hold the greatest promise for future revenue growth,” with the cutbacks “preserving resources for key projects,” Glover said.
Additionally, he said that the company continues to pursue expanded reimbursement coverage from the Centers for Medicare & Medicaid Services (CMS; Baltimore) for angina treatment with EECP and new coverage for CHF treatment.
Underlining that effort, Vasomedical is pursuing publication of the PEECH trial results in a major peer-reviewed journal, Glover said.
The company’s restructuring also will target, it said, “strategies directed at key projects essential to current and future growth. These are: the continued development of critical clinical data to support Vasomedical’s EECP therapy, the continued growth of the service related business, the maintenance of the company’s FDA and international quality and regulatory compliance programs as well as technical and product development support.”
“This initiative, coupled with the cost saving measures, will make us a leaner and more effective organization which is better suited to capitalize on the large CHF market opportunity while continuing to effectively service our current market base,” Glover said.
The company primarily bills EECP therapy as an effective non-invasive strategy for increasing circulation in the heart restoring “systemic vascular function.” The therapy typically is delivered in 35 one-hour-sessions over seven weeks. Patients lie down on a padded table and their calves, lower thighs and upper thighs are wrapped in a cuff set. The system, which is synchronized to the individual patient’s cardiac cycle, inflates the cuffs with air to create external pressure when the heart is resting (diastole) and deflates the cuffs just before the heart beats (systole).
Vasomedical provides hospitals, clinics and private practices with EECP equipment, treatment guidance and a staff training and maintenance program.