In the first quarter, the Company launched its first therapeutic product, the SENSUS Pain Management System. SENSUS is a transcutaneous electrical nerve stimulator intended for the symptomatic relief and management of chronic intractable pain. It is the only device designed specifically for people with chronic neuropathic pain. The most common cause of such pain in people with diabetes is painful diabetic neuropathy (PDN), which affects 3 to 5 million patients in the US alone. Most patients with PDN have moderate to severe pain and half have sleep disturbances due to their pain. SENSUS offers physicians and their patients a non-narcotic pain relief option as a complement to medications. The device is lightweight, can be worn during the day, and may be used at bedtime before going to sleep. It is activated by the press of a single button.
SENSUS related activity in Q1 included:
- Initial commercial shipments of 145 SENSUS devices during the quarter. Feedback from patients has been encouraging with reports of a substantial decrease in pain and improved sleep.
- Sales channel development leading to ten regional DME suppliers.
- Discussions with potential distributors having national footprints that, if successful, could lead to a substantial increase in product sales.
- Design and preparation of a post-market 6-week open-label evaluation of pain relief in patients with moderate to severe PDN using SENSUS. The primary outcome measure is a statistically significant improvement in the pain and interference scores on the Brief Pain Inventory (BPI).
- Filing of a 510(k) for expanded indications relating to device use during sleep. The current device may be used at bedtime prior to sleep. This 510(k) submission, if successful, will give SENSUS unique regulatory labeling for electrical stimulation during sleep.
- Important R&D progress including improvements to ease of use, support for use during sleep, and development of a second generation device.
- Launch of a SENSUS website with disease information and product support for patients, physicians, and distributors.
NC-stat® DPNCheck® is the Company’s fast,
accurate, quantitative and cost effective test for DPN. In the US, the
product is primarily marketed to
“The launch of our first therapeutic product was an important milestone
for NeuroMetrix,” said
The Company reported its financial results for the first quarter of
2013. Total revenues were
Company to Host Live Conference Call and Webcast
NeuroMetrix is a medical device company that develops and markets home
use and point-of-care devices for the treatment of diabetic
neuropathies, which affect over 50% of people with diabetes. If left
untreated, diabetic neuropathies trigger foot ulcers that may require
amputation and cause disabling chronic pain. The annual cost of diabetic
neuropathies has been estimated at $14 billion in the
Safe Harbor Statement
The statements contained in this press release include forward-looking
statements within the meaning of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended, including, without limitation, statements regarding
the company’s or management’s expectations relating to the adoption of
NC-stat DPNCheck and SENSUS, our ability to build a successful business
focused on diabetic peripheral neuropathy, and our hope of expanding our
commercial sales channel of our diabetic neuropathy products. While the
company believes the forward-looking statements contained in this press
release are accurate, there are a number of factors that could cause
actual events or results to differ materially from those indicated by
such forward-looking statements, including, without limitation, our
estimates of future performance, and our ability to successfully
develop, receive regulatory clearance or approval, commercialize and
achieve market acceptance for any of our products. There can be no
assurance that future developments will be those that the company has
anticipated. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors including those risks,
uncertainties and factors referred to in the company’s most recent
Annual Report on Form 10-K as well as other documents that may be filed
from time to time with the
|Condensed Statements of Operations|
|Cost of revenues||569,784||1,134,944|
|Research and development||1,073,419||978,066|
|Sales and marketing||779,841||1,534,101|
|General and administrative||1,233,594||1,191,064|
|Total operating expenses||3,086,854||3,703,231|
|Loss from operations||(2,255,184||)||(2,756,633||)|
|Net loss per common share data, basic and diluted||$||(1.06||)||$||(1.99||)|
Note: per share amounts have been adjusted to reflect the Company’s
1:6 reverse stock-split which occurred on February 15, 2013.
|Condensed Balance Sheets|
|Cash and cash equivalents||$||6,886,191||$||8,699,478|
|Other current assets||1,741,790||1,873,588|
|Total liabilities and stockholders’ equity||$||8,891,202||$||10,877,447|
Thomas T. Higgins, 781-314-2761
SVP and Chief Financial Officer