Latest news with #InvestigationalDeviceExemption
Associated Press
20-05-2025
- Business
- Associated Press
FDA Grants Atia Vision Approval to Begin US Clinical Trial of OmniVu™ Lens System in Patients with Cataracts
CAMPBELL, Calif.--(BUSINESS WIRE)--May 20, 2025-- Atia Vision, Inc., a Shifamed portfolio company, today announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a traditional feasibility clinical study of its OmniVu™ Lens System. This novel intraocular lens is designed to restore dynamic range of vision following cataract surgery, going beyond the capabilities of current presbyopia-correcting lenses. This press release features multimedia. View the full release here: OmniVu™ Lens System 'This IDE approval marks a pivotal milestone in our mission to transform the standard of care for cataract patients,' said Mariam Maghribi, CEO of Atia Vision. 'OmniVu was developed to solve for the limitations of both accommodative and traditional lenses. Our technology represents a significant advancement in lens design by addressing both optical and functional compromises found in current solutions.' The OmniVu Lens System is comprised of two distinct components: a fluid-filled shape-changing base that provides focusing capability, or zoom function, and a front optic that docks into the base provides the optical power. Additionally, engineered with a more physiologic shape to fill the capsular bag, the OmniVu Lens System is expected to preserve the eye's anatomic integrity and elasticity. This advanced design aims to provide patients with a more natural visual experience across all distances that continues to perform over time. 'The final frontier for lens surgery is an intraocular lens that combines outstanding distance vision with dynamic focusing that maintains excellent image quality,' said Dr. George Waring, IV, medical advisory board member for Atia Vision. 'The global outcomes to date demonstrate the real potential the OmniVu Lens System has to address the unanswered opportunities with current lens technology, such as a continuous visual range, refractive predictability and stability, all while minimizing visual trade-offs.' The OmniVu Lens System has been evaluated internationally in both first-in-human and feasibility clinical trials with over 75 lenses implanted to date and follow-up extending to three years. Clinical results thus far demonstrate continuous range of focus from far through near with 100% of patients achieving 20/20 or better uncorrected distance vision. Preliminary contrast sensitivity and patient-reported outcomes data demonstrate the potential for parity with monofocal lenses, the current standard for visual quality after cataract surgery. Approximately 94 million people worldwide are visually impaired due to cataracts. 1 Traditional monofocal and presbyopia-correcting lens options are static designs that force patients to compromise between high-quality vision with narrow focus or range of vision with reduced quality. Despite 100% of patients needing to see clearly from near to far, presbyopia-correcting lens adoption remains low at only 6.2% globally. 2 About Atia Vision, Inc. Atia Vision is developing a modular presbyopia-correcting intraocular lens to address the full range of vision for patients with cataracts and presbyopia. The accommodating lens technology is designed to provide superior visual outcomes with an excellent safety profile and be uniquely customizable to address patients' evolving vision needs. Founded in 2014, Atia Vision's technology originated from the Shifamed portfolio, a Silicon Valley-based medical innovation hub. For more information, visit About Shifamed LLC Founded by serial entrepreneur Amr Salahieh, Shifamed LLC is a highly specialized medical innovation hub focused on developing advanced solutions that accelerate time to market, reduce risk, increase impact, and forge a path toward a world where patients are able to lead longer, healthier lives. To learn more about Shifamed, please visit The OmniVu™ Lens System is an investigational device and is not approved for sale in any market. References: View source version on CONTACT: Media Contact: Silvana Guerci-Lena Phone: 508-808-8993 Email:[email protected] KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: MEDICAL DEVICES FDA HEALTH SURGERY CLINICAL TRIALS OPTICAL SOURCE: Atia Vision Copyright Business Wire 2025. PUB: 05/20/2025 09:03 AM/DISC: 05/20/2025 09:02 AM
Business Wire
20-05-2025
- Business
- Business Wire
FDA Grants Atia Vision Approval to Begin US Clinical Trial of OmniVu™ Lens System in Patients with Cataracts
CAMPBELL, Calif.--(BUSINESS WIRE)--Atia Vision, Inc., a Shifamed portfolio company, today announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a traditional feasibility clinical study of its OmniVu™ Lens System. This novel intraocular lens is designed to restore dynamic range of vision following cataract surgery, going beyond the capabilities of current presbyopia-correcting lenses. "This IDE approval marks a pivotal milestone in our mission to transform the standard of care for cataract patients," said Mariam Maghribi, CEO of Atia Vision. "OmniVu was developed to solve for the limitations of both accommodative and traditional lenses. Our technology represents a significant advancement in lens design by addressing both optical and functional compromises found in current solutions." The OmniVu Lens System is comprised of two distinct components: a fluid-filled shape-changing base that provides focusing capability, or zoom function, and a front optic that docks into the base provides the optical power. Additionally, engineered with a more physiologic shape to fill the capsular bag, the OmniVu Lens System is expected to preserve the eye's anatomic integrity and elasticity. This advanced design aims to provide patients with a more natural visual experience across all distances that continues to perform over time. "The final frontier for lens surgery is an intraocular lens that combines outstanding distance vision with dynamic focusing that maintains excellent image quality," said Dr. George Waring, IV, medical advisory board member for Atia Vision. "The global outcomes to date demonstrate the real potential the OmniVu Lens System has to address the unanswered opportunities with current lens technology, such as a continuous visual range, refractive predictability and stability, all while minimizing visual trade-offs." The OmniVu Lens System has been evaluated internationally in both first-in-human and feasibility clinical trials with over 75 lenses implanted to date and follow-up extending to three years. Clinical results thus far demonstrate continuous range of focus from far through near with 100% of patients achieving 20/20 or better uncorrected distance vision. Preliminary contrast sensitivity and patient-reported outcomes data demonstrate the potential for parity with monofocal lenses, the current standard for visual quality after cataract surgery. Approximately 94 million people worldwide are visually impaired due to cataracts. 1 Traditional monofocal and presbyopia-correcting lens options are static designs that force patients to compromise between high-quality vision with narrow focus or range of vision with reduced quality. Despite 100% of patients needing to see clearly from near to far, presbyopia-correcting lens adoption remains low at only 6.2% globally. 2 About Atia Vision, Inc. Atia Vision is developing a modular presbyopia-correcting intraocular lens to address the full range of vision for patients with cataracts and presbyopia. The accommodating lens technology is designed to provide superior visual outcomes with an excellent safety profile and be uniquely customizable to address patients' evolving vision needs. Founded in 2014, Atia Vision's technology originated from the Shifamed portfolio, a Silicon Valley-based medical innovation hub. For more information, visit About Shifamed LLC Founded by serial entrepreneur Amr Salahieh, Shifamed LLC is a highly specialized medical innovation hub focused on developing advanced solutions that accelerate time to market, reduce risk, increase impact, and forge a path toward a world where patients are able to lead longer, healthier lives. To learn more about Shifamed, please visit The OmniVu™ Lens System is an investigational device and is not approved for sale in any market. 2021 Market Scope IOL Report
Miami Herald
19-05-2025
- Business
- Miami Herald
enVVeno Medical Appoints Jennifer Bright as Chief Financial Officer
IRVINE, CA / ACCESS Newswire / May 19, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, announced the appointment of Jennifer Bright as Chief Financial Officer, effective today, May 19, 2025. Ms. Bright brings more than 25 years of financial and strategic leadership experience built across several commercial-stage medical device and pharmaceutical companies including Biolase, Spectrum Pharmaceuticals, Apria Healthcare, Smile Brands, and Teleflex Medical, as well as technical accounting and auditing experience at PricewaterhouseCoopers LLP. "Jennifer brings a wealth of commercial experience to the CFO role, which we believe will be instrumental as we transition from a development-stage company to a commercial entity," said Robert Berman, enVVeno Medical's Chief Executive Officer. "In addition to overseeing our financial strategy and operations, Jennifer will play a critical role in strengthening our financial infrastructure, supporting our commercialization efforts for VenoValve, and expanding our relationships with institutional investors and analysts. Her experience navigating growth and change will be a valuable asset as we enter this next phase of the Company's evolution." Ms. Bright is a Certified Public Accountant and received a B.A. degree in Business Administration, Accounting, from the University of Washington. She succeeds Craig Glynn, who will continue to be available to the Company in an advisory capacity. The Company is currently developing two devices for the treatment of deep venous CVI, a potential first-in-class surgical replacement venous valve called the VenoValve®, and a non-surgical replacement venous valve called enVVe®. The Company estimates that there are approximately 2.5 million potential new patients each year in the U.S. that could be candidates for replacement venous valves, including approximately 1.5 million with active venous ulcers. The Company has submitted a pre-market authorization (PMA) application for the VenoValve to the FDA, with a decision anticipated in the second half of 2025. In the third quarter of 2025, the Company expects to file an Investigational Device Exemption (IDE) seeking authorization from the FDA to begin enVVe pivotal trial. About CVISevere, deep venous Chronic Venous Insufficiency (CVI) is a debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, dressing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence. Estimates indicate that CVI costs the U.S. healthcare system in excess of $4 billion each year. About enVVeno Medical CorporationenVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company's lead product, the VenoValve®, is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous CVI. The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe®. CVI occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal and become chronic. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The Company has submitted a pre-market authorization (PMA) application for the VenoValve to the FDA, with a decision anticipated in the second half of 2025 and is currently performing the final testing necessary to seek approval from the FDA for the enVVe pivotal trial. Cautionary Note on Forward-Looking StatementsThis press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results and timing may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law. ### INVESTOR CONTACT:Jenene Thomas, JTC Team, LLCNVNO@ 824-0775 MEDIA CONTACT:Glenn Silver, FINN 818-8198 SOURCE: enVVeno Medical Corporation
Technical.ly
16-05-2025
- Business
- Technical.ly
Biotech startup BioLattice wins pitch prize — but says the real value was showing up
Despite the international representation at BioLabs Philadelphia's third annual Investor Day, a local biotech company took home the top prize. Amelia Zellander, founder and CEO of tissue engineering startup BioLattice, applied for Investor Day as a way to attract funding and resources for her company, with the goal of making connections that could lead to valuable relationships, she said. The event featured 18 startups, all of which pitched to win Startup of the Year and a package of consulting services, software services and discounts on equipment. The startups were also exposed to life sciences stakeholders from across the country and those from outside the region got to meet Philly's ecosystem. Winning Startup of the Year means a lot, Zellander said, and helps to spread the word about the work she is doing. 'People invest in people they know and they like,' she told 'You just have to have face-to-face interaction, and nothing magical is going to happen for me at this one event. It's about being out there a lot.' Recognition from winning the award will help Zellander with her current goal, raising a $2 million seed round. The seed round will help the company file for an Investigational Device Exemption (IDE) from the Food and Drug Administration to generate data to show that the company is ready for a clinical trial, Zellander said. BioLattice is developing a biomaterial to repair and transplant the front layer of the eye called CorneaClear. The company has seen some momentum over the last few years, receiving funding from federal agencies, accelerators and pitch competitions that have supported the development of its prototype. It has some early data from animal tests to inform its pilot studies, but still needs more cash to get there. A slow funding environment isn't scaring BioLattice away Despite Zellander's recent wins, her experience with finding funding and resources for her company has always been a challenge. It's generally harder for life sciences companies to find funding because they're high risk and require long timelines. Lack of funding is exacerbated by funding cuts to the National Institutes of Health. The Philadelphia region saw a dip in venture capital last quarter and Philly companies say they are having trouble securing funding from local investors. Events like BioLabs Investor Day are intended to bring investors and money from outside Philadelphia into the region, Melina Blees, head of BioLabs Philadelphia, told But investors generally are looking for companies with strong teams that are capital efficient, have an exit timeline and proven customers. Plus, federal funding cuts are making it increasingly difficult for startups to get off the ground. However, these circumstances don't particularly scare Zellander, she said. Raising money and finding resources have always been difficult. In the past, she struggled to find consistent funding and balance her time building the startup while working full-time jobs, she said. 'It has just never been easy, and in my experience, it's always hard for just different reasons,' she said. Bringing outsiders to Philly to boost local VC BioLabs hosts events like this not just to engage with local stakeholders, but also to show off the region to investors who may write Philly off, Blees of BioLabs said. 'Our goal is really to bring them here, to show them that there's great science happening,' Blees said. 'Then hopefully that means they come back and they invest.' Biolabs' national presence is helpful for this, she said. The global life sciences coworking company hosts an investor event series in its hubs across the country, which works to build a network that can be tapped into by anyone. BioLabs launched in Philly in 2018 and is now doubling down on its presence here. The company recently announced plans to expand its space at the Curtis building. The BioLabs for Advanced Therapeutics will be a 30,000-square-foot incubator space to be completed in the second half of this year. The expansion includes the opening of the Thermo Fisher Scientific Advanced Therapies Collaboration Center, which is expected to bring in companies from all over to try equipment and work with the life science company's team, Blees said. Convincing investors that startups can be successful anywhere is easier since the pandemic introduced virtual work, she said. In fact, startups can be more successful in an ecosystem where they have connections and resources with a lower cost of living. 'Money can move,' Blees said. 'If a great company is embedded in an ecosystem and has the support and has resources, why would you move them?' Sarah Huffman is a 2022-2024 corps member for Report for America, an initiative of The Groundtruth Project that pairs young journalists with local newsrooms. This position is supported by the Lenfest Institute for Journalism.
Yahoo
14-05-2025
- Business
- Yahoo
Glucotrack Reports First Quarter 2025 Financial Results and Recent Corporate Highlights
On track to implant first patients in long-term, multicenter feasibility study of the fully implantable continuous blood glucose monitor (CBGM) system in Australia in Q3 2025 Investigational Device Exemption (IDE) approval for novel CBGM technology from FDA expected in Q4 2025 Rutherford, NJ, May 14, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) ('Glucotrack' or the 'Company'), a medical technology company focused on the design, development, and commercialization of novel technologies for people with diabetes, today reported financial results and recent corporate highlights for the first quarter ended March 31, 2025. 'I am pleased with the progress we made during the quarter and look forward to commencing our clinical study in Australia, where we expect to continue growing our body of clinical evidence to support the use of our well-differentiated, fully implantable, real-time, multi-year continuous blood glucose monitoring system,' said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. 'At the same time, we remain focused on strengthening our capital structure and ensuring that we have the runway to bring our potentially life-improving technology to the millions of diabetes patients who need it most.' First Quarter 2025 & Recent Highlights Advanced Product and Clinical Development Received ethical approval in Australia to initiate long-term clinical study of the Company's continuous blood glucose monitor (CBGM) in participants with type 1 and type 2 diabetes. Announced participation in FORGETDIABETES, a prominent European research initiative dedicated to developing an immuno-optimized, fully-implantable, fully-automated, artificial pancreas for people with type 1 diabetes. Glucotrack's CBGM technology will provide real-time glucose data to guide insulin dosing decisions within the artificial pancreas. Announced collaboration with OneTwo Analytics to apply advanced artificial intelligence and machine learning analytics to clinical study data from the Company's CBGM. The partnership aims to generate deeper insights into the performance and clinical impact of the Company's technology. Successfully completed a first-in-human clinical study of the CBGM that met its primary endpoint with no procedure- or device-related serious adverse events reported. The study confirmed successful function and placement of the sensor lead in the subclavian vein, and demonstrated solid Bluetooth performance with accuracy comparable to animal studies. These data were presented at the 2025 International Conference on Advanced Technologies & Treatment for Diabetes (ATTD). Received ISO 13485:2016 certification from the British Standards Institute (BSI) demonstrating our commitment and ability to meet rigorous global standards for design and manufacturing of high-quality medical devices. Anticipated Milestones in 2025 Presenting clinical data demonstrating the safety and accuracy of the CBGM at additional industry conferences. Further expanding Advisory Boards with world-renowned experts in endocrinology and cardiology and others essential to the diabetes community. Implanting first patients in long-term, multicenter feasibility study of the fully implantable CBGM system in Australia, anticipated in Q3 2025. Securing IDE approval from the U.S. Food and Drug Administration for a long-term, multicenter Pilot Study of the CBGM system, anticipated in Q4 2025, subject to current agency response timelines. Financial Results for the Quarter ended March 31, 2025 Research and Development Expenses: Research and development expenses were $1.9 million for first quarter of 2025 compared to $2.1 million for first quarter of 2024. The decrease of $0.2 million was primarily due to timing in product and manufacturing development activities. Marketing, General and Administrative Expenses: Marketing, General and Administrative expenses were $1.6 million for the first quarter of 2025 compared to $0.8 million for first quarter of 2024. The increase of $0.8 million was primarily attributable to increased legal and professional fees and personnel costs. Net Loss: Net loss for the first quarter of 2025 was $6.8 million compared to a net loss of $2.9 million for the first quarter of 2024. The increase in net loss is attributable primarily to the non-cash $3.4 million change in fair value of derivative liabilities and increase of $0.5 million in operating expenses. Cash Position: Cash and cash equivalents as of March 31, 2025, were $9.1 million, compared with $5.6 million in cash and cash equivalents as of December 31, 2024. The net increase in cash and cash equivalents was attributable to the $6.4 million received from financing activities offset by cash used in operating and investing activities of $2.9 million. Based on current plans and assumptions, the Company believes that its existing cash and cash equivalents will be sufficient to fund its 2025 operating plan to initiate human clinical trials and related milestones. The Glucotrack Continuous Blood Glucose Monitor is an Investigational Device and is limited by federal (or United States) law to investigational use. For more information about Glucotrack's CBGM, visit Information on the Company's website does not constitute a part of and is not incorporated by reference into this press release. About Glucotrack, Inc. Glucotrack, Inc. (NASDAQ: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes. Glucotrack's CBGM is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. For more information, please visit Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as 'anticipate', 'believe', 'expect', 'plan' and 'will' are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack's results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack's future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack's filings with the U.S. Securities and Exchange Commission (the 'SEC'), including its Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on March 31, 2025. Contacts: Investor Relations: Media: investors@ GlucotrackPR@ GLUCOTRACK CONSOLIDATED BALANCE SHEETS(in thousands of US dollars except share data) In thousands of US dollars(except stock data) March 31,2025 December 31,2024 Unaudited Current Assets Cash and cash equivalents 9,100 5,617 Other current assets 355 151 Total current assets 9,455 5,768 Operating lease right-of-use asset, net 53 59 Property and equipment, net 94 95 Restricted cash 10 10 TOTAL ASSETS 9,612 5,932 LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) Current Liabilities Accounts payable 1,612 992 Operating lease liability, current 26 26 Convertible promissory notes 9 5 Other current liabilities 303 252 Total current liabilities 1,950 1,275 Non-Current Liabilities Derivative financial liabilities (Note 2F and Note 3B) 177 17,421 Operating lease liability, non-current 26 33 Loans from stockholders 201 203 Total liabilities 2,354 18,932 Commitments and contingent liabilities (Note 4) Stockholders' Equity (Deficit) Common Stock of $0.001 par value ('Common Stock'): 250,000,000 and 100,000,000 shares authorized as of March 31, 2025 and December 31, 2024, respectively; 25,585,853 and 791,609 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively 26 1 Additional paid-in capital 146,259 119,229 Receipts on account of shares 228 228 Accumulated other comprehensive income 28 (8 ) Accumulated deficit (139,283 ) (132,450 ) Total stockholders' equity (deficit) 7,258 (13,000 ) TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) 9,612 5,932 GLUCOTRACK CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(in thousands of US dollars except share data) (unaudited) Three-month period endedMarch 31, 2025 2024 Operating expenses Research and development $ 1,871 $ 2,148 General and administrative 1,499 733 Selling and marketing expenses 128 70 Total operating expenses 3,498 2,951 Operating loss 3,498 2,951 Other (income) expense Change in fair value of derivative liabilities 3,376 - Other (income) expense, net (4 ) - Finance expenses (income), net (37 ) (24 ) Net Loss 6,833 2,927 Other comprehensive income: Foreign currency translation adjustment (36 ) (6 ) Comprehensive loss for the period $ 6,797 $ 2,921 Basic and diluted net loss per common stock $ (0.67 ) $ (11.73 ) Weighted average number of common stock used in computing basic and diluted loss per common stock 10,160,725 249,598 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
