There was encouraging progress in the diabetes business as the Company accelerated sales of NC-stat® DPNCheck™, its diagnostic test for the evaluation of peripheral neuropathies such as diabetic peripheral neuropathy (DPN). DPN affects over 50% of people with diabetes and causes significant morbidity including pain, increased risk of falling in the elderly, and is the primary trigger for diabetic foot ulcers which may require lower extremity amputations. The Company also reported progress in commercializing its R&D pipeline with the SENSUS™ pain management device which is targeted for market launch in the fourth quarter of 2012.
Recent highlights include:
Penetration of the managed care market was initiated with a
substantial order from
WellMed Medical Group of San Antonio, TX.WellMed provides care to approximately 100,000 Medicare Advantagepatients and plans to regularly evaluate its patient population for peripheral neuropathies such as DPN. During the second quarter NC-stat DPNCheck devices and consumables were delivered to WellMed, training was completed and product use has started. Managed care represents the most compelling near term market opportunity for NC-stat DPNCheck.
Retail health is an important market where the Company is building a
presence. During the second quarter, the Company filled a large order
Wal-Mart Canada Corp.and Wal-Martbegan to offer foot examinations, with NC-stat DPNCheck as a key component, at its Canadian pharmacies that have a diabetes focus.
- The strategically important endocrinology and podiatry markets continued to show progress in NC-stat DPNCheck device placements at the pace seen in preceding quarters.
- The installed base of NC-stat DPNCheck devices reached 500 in May and now stands at 590. The Company is at a pace to achieve its goal of 1,000 devices in the market by year end.
Commercial launch of SENSUS remains on track for the fourth quarter.
The Company filed a 510(k) submission with the
FDAin April 2012and subsequent requests for additional information have been promptly addressed by the Company. The Company filed a second 510(k) submission in June 2012for the Company’s proprietary SENSUS electrode. This single-patient electrode will provide 1-2 weeks of use and represents a recurring revenue stream from use of the SENSUS product.
American Diabetes Association(ADA) meeting provided an opportunity for the Company to discuss its products and pipeline with leaders in the diabetes community.
“Our recent successes in managed care and retail health are
The Company reported its financial results for the second quarter of
2012. Total revenues were
For the six month period ended
Company to Host Live Conference Call and Webcast
Safe Harbor Statement
The statements contained in this press release include forward-looking
statements within the meaning of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended, including, without limitation, statements regarding
the company’s or management’s expectations relating to the adoption of
NC-stat DPNCheck, our ability to build a successful business focused on
diabetic peripheral neuropathy, and our hope of expanding our commercial
sales channel of our diabetic neuropathy products. While the company
believes the forward-looking statements contained in this press release
are accurate, there are a number of factors that could cause actual
events or results to differ materially from those indicated by such
forward-looking statements, including, without limitation, our estimates
of future performance, including the expected timing of the launch of
our SENSUS product; the timing, costs and other limitations involved in
obtaining regulatory clearance or approval for our SENSUS product; and
our ability to successfully develop, receive regulatory clearance or
approval, commercialize and achieve market acceptance for any of our
products. There can be no assurance that future developments will be
those that the company has anticipated. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors
including those risks, uncertainties and factors referred to in the
company’s most recent Annual Report on Form 10-K as well as other
documents that may be filed from time to time with the
|Condensed Statements of Operations|
|Cost of revenues||983,350||1,110,073||2,118,294||2,365,648|
|Research and development||1,020,726||1,123,509||1,998,792||2,220,331|
|Sales and marketing||1,595,642||1,479,519||3,129,743||3,354,129|
|General and administrative||1,382,268||1,301,476||2,573,332||2,683,571|
|Total operating expenses||3,998,636||3,904,504||7,701,867||8,258,031|
|Loss from operations||(2,776,155||)||(2,442,737||)||(5,532,788||)||(5,146,993||)|
|Net loss per common share, basic and diluted||$||(0.22||)||$||(0.63||)||$||(0.53||)||$||(1.33||)|
Note: per share amounts have been adjusted to reflect the Company’s 1:6
reverse stock-split which occurred on
|Condensed Balance Sheets|
|Cash and cash equivalents||$||13,324,824||$||10,290,446|
|Other current assets||1,972,847||3,204,860|
|Total liabilities and stockholders’ equity||$||15,682,447||$||14,220,783|
Thomas T. Higgins, 781-314-2761
Chief Financial Officer