Press Releases
"We have taken an important step to expand the availability of Quell® Fibromyalgia in key
Recent Business Highlights:
- The Company reported positive results from its strategic launch of Quell Fibromyalgia. There were 123 unique prescribers during Q2 compared to 92 during Q1. The cumulative number of Quell Fibromyalgia prescriptions that have been written increased to 490 in Q2 from 234 in Q1, with approximately 60% of prescriptions filled by patients. The cumulative number of month-refills increased to 348 in Q2 from 141 in Q1.
- In light of the encouraging early Quell Fibromyalgia experience, the Company announced a sales force expansion to drive further adoption. The next stage of the commercialization process will focus on the
Texas ,California andFlorida markets.
The University of Rochester School of Medicine and Dentistry reported results of anNIH -funded multi-center randomized sham-controlled trial of Quell for CIPN. Subjects with moderate to severe CIPN symptoms of hot/burning pain, sharp/shooting pain or muscle cramping experienced about a 50% reduction in symptoms for active Quell treatment compared to about 30% for sham Quell treatment. The Company expects to make a 510(k) filing with the FDA in Q4 of this year. The use of Quell for moderate to severe CIPN received a FDA breakthrough designation inJanuary 2022 .
- Several Quell clinical trials are active and enrolling, including for fibromyalgia-like long COVID, chronic overlapping pain conditions (COPC) and peripheral edema. These indications represent potential new or expanded labels for the Quell prescription neurotherapeutics platform.
- The
University of Sheffield diabetes research group reported results of a prospective study of abnormal sural nerve function, detected using DPNCheck and a complimentary technology, which predicts all-cause mortality in type 2 diabetes, even after adjusting for cardiovascular and other risk factors. Hence, early-stage diagnosis using DPNCheck is vital to identifying the risk of potentially devastating health complications.
- Two large recently published clinical studies support the clinical utility of DPNCheck in screening people with diabetes. Ke and colleagues developed an algorithm to predict progression to vision threatening diabetic retinopathy based on DPNCheck testing. Fukuda and colleagues analyzed the correlation of diabetic peripheral neuropathy to kidney function and found that DPNCheck test results were an independent predictor of kidney disease.
Financial Results:
Financial results in Q2 2023 were in line with the Company’s expectations. This follows the Q1 2023 disruption to the Medicare Advantage market by CMS with its changes to Risk Adjustment Data Validation (RADV) and to risk adjustment calculations. Revenue in Q2 2023 of
Revenues in H1 2023 of
The Company ended the period with
Company to Host Live Conference Call and Webcast
About
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 regarding the business, as well as events that could have a meaningful impact on the company’s revenues and cash resources. 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, estimates of future performance, and the ability to successfully develop, receive regulatory clearance, commercialize and achieve market acceptance for any 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, Quarterly Reports on Form 10-Q, as well as other documents that may be filed from time to time with the
Source:
SVP and Chief Financial Officer
neurometrix.ir@neurometrix.com
Statements of Operations (Unaudited) |
|||||||||||||||
| Quarters Ended |
Six Months Ended |
||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Revenues | $ | 1,655,744 | $ | 2,138,301 | $ | 3,380,515 | $ | 4,440,692 | |||||||
| Cost of revenues | 536,486 | 686,121 | 1,062,858 | 1,194,995 | |||||||||||
| Gross profit | 1,119,258 | 1,452,180 | 2,317,657 | 3,245,697 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 753,509 | 915,799 | 1,452,934 | 1,626,376 | |||||||||||
| Sales and marketing | 744,963 | 566,598 | 1,560,835 | 1,425,437 | |||||||||||
| General and administrative | 1,244,241 | 1,180,101 | 2,637,412 | 2,366,192 | |||||||||||
| Total operating expenses | 2,742,713 | 2,662,498 | 5,651,181 | 5,418,005 | |||||||||||
| Loss from operations | (1,623,455 | ) | (1,210,318 | ) | (3,333,524 | ) | (2,172,308 | ) | |||||||
| Other income | 86,426 | 50,395 | 222,321 | 53,823 | |||||||||||
| Net loss | $ | (1,537,029 | ) | $ | (1,159,923 | ) | $ | (3,111,203 | ) | $ | (2,118,485 | ) | |||
| NeuroMetrix, Inc. Condensed Balance Sheets (Unaudited) |
||||||||
2023 |
2022 |
|||||||
| Cash, cash equivalents and securities | $ | 19,627,209 | $ | 21,199,727 | ||||
| Other current assets | 2,662,197 | 2,907,260 | ||||||
| Noncurrent assets | 484,097 | 562,628 | ||||||
| Total assets | $ | 22,773,503 | $ | 24,669,615 | ||||
| Current liabilities | $ | 1,209,929 | $ | 1,106,412 | ||||
| Lease obligation, net of current portion | 152,143 | 207,516 | ||||||
| Stockholders’ equity | 21,411,431 | 23,355,687 | ||||||
| Total liabilities and stockholders’ equity | $ | 22,773,503 | $ | 24,669,615 | ||||
Source: NeuroMetrix, Inc.