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New words:
absorption, ACA, Academy, accident, accidental, ActivOrtho, acute, adjourn, Adjournment, admiral, Advisor, affirmatively, Affordable, Amersham, Anderson, apnea, Arlington, arrearage, arterial, Asia, Bachelor, background, Bank, banking, Bauer, Bay, billion, biopharmaceutical, biosynthetic, biotechnology, BMY, bone, Boston, broaden, BSX, buyout, CA, Caisson, Cameron, Cancer, cardiology, cardiometabolic, career, Catania, CFO, chair, chaired, chairman, Chairwoman, Chapter, Clawback, cloud, College, Colorado, Compaq, compatible, conferring, Connecticut, counsel, CPRA, cybersecurity, Dakota, DC, deceptive, dental, Devax, disaster, disclose, discriminate, disgorgement, displayed, diversified, division, Dr, East, Eddie, educational, EEA, eluting, Embarcadero, encryption, EndiCor, endovascular, eNeura, entail, epilepsy, ERC, erroneously, essentially, eSTAR, expend, expert, explicit, expressly, extortion, fault, FDB, fixation, fraction, fractional, fracture, Francisco, Galea, GE, Gem, Gemphire, geopolitical, George, globe, graduate, Greenwich, grew, Havemeyer, HCTI, HDI, HDL, Heart, hereof, HLUYY, honor, Hudson, improper, improperly, inChord, incident, inconsistent, increasingly, incumbent, Indiana, injunctive, insight, inVentiv, Iowa, issuable, JNJ, Johnson, Jude, Julian, Kluwer, Lauder, Leaf, Lee, LivaNova, LIVN, LP, LUN, Lundbeck, machinery, Maple, Mary, Matthew, MBA, MD, MeadWestvaco, Mentoring, Michigan, Micro, Microvena, Middle, migraine, Minnetronix, Miromatrix, misconduct, Mississippi, molecule, monetization, Montana, multiplying, Myocardial, narrative, Naval, Navy, Neuro, NeuroBo, neurologist, neuromuscular, NeuroOne, Neuropharma, NexGen, NMTC, nominee, NRBO, NUWE, NYSE, Ockner, Odyssey, Osprey, Panbela, pancreatic, Panther, payor, PBLA, pension, permissible, pertinent, physiotherapy, PLC, Ply, Prizm, professor, promptly, put, QP, quantity, question, questionable, rare, reapplied, recuse, redeemed, redemption, regenerative, repurchase, Rescue, retired, revoking, Robertson, rotation, Roth, rounded, Ryder, salary, San, School, Scimed, sector, seeded, Sentreheart, Shire, Shoulder, sinking, solution, Southeast, specialist, SPHG, Squibb, St, store, StratMedica, subacute, substituted, supplier, Surgery, Synaerion, Talisman, Teewinot, Tennessee, teva, Thera, Thornton, tied, Tiger, transferrable, transformation, Triangle, unaffected, Unconditional, undue, unvested, USN, Utah, vacation, Velocimed, vendor, Venture, vetting, Virginia, waiver, Wall, Washington, withdrawn, young
Removed:
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Financial report summary
?Risks
- We have incurred substantial net losses since our inception and anticipate that we will continue to incur substantial net losses for the foreseeable future. We may never achieve or sustain profitability.
- We will require additional financing to carry out our plan of operations and if we are unable to obtain such financing, our business may fail.
- Raising additional capital by issuing securities or through debt financings or licensing arrangements may cause significant dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product on terms unfavorable to us.
- Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements. We may be unable to continue to operate without the threat of liquidation for the foreseeable future.
- We currently only have one product which is approved in the U.S. only for treatment of gait deficit, for MS and otherwise only in Canada and Australia.
- Our PoNS technology is a novel form of neurostimulation therapy, and the medical community tends not to adopt new therapies very rapidly. If physicians elect not to prescribe the PoNS Therapy, we will be unable to generate significant revenue.
- There is limited market awareness of our product, and the neuromodulation market is new and uncertain.
- We face significant competition in an environment of rapid technological change, and our competitors may develop devices or products that are more advanced or more effective than ours are which may adversely affect our financial condition and our ability to successfully market the PoNS device.
- We are, and will continue to be, dependent in significant part on outside scientists and third-party research institutions for our research and development in order to be able to commercialize our product.
- We depend on third parties for the manufacture and distribution of our product and the loss of our third-party manufacturer and distributor could harm our business.
- If our intellectual property protection is inadequate, competitors may gain access to our technology and undermine our competitive position.
- We may be subject to various litigation claims and legal proceedings, including intellectual property litigation, such as patent infringement claims, which could adversely affect our business.
- There are risks to our intellectual property based on our international business operations.
- Before we can market and sell our products for additional indications, we are required to obtain marketing authorization and/or certification from the FDA and foreign regulatory authorities. These authorizations and/or certifications will take significant time and require significant research, development, and clinical study expenditures, and ultimately may not succeed.
- Obtaining and maintaining FDA marketing authorization will be costly, may result in time-consuming delays and will subject us to ongoing compliance costs and regulatory risk for non-compliance.
- We have in the past and may be required to conduct clinical trials to support a de novo submission or PMA application for the PoNS device with respect to one or more indications and we expect to be required to conduct clinical trials to support regulatory marketing authorization for future product candidates.
- We have and may continue to encounter substantial delays in planned clinical trials, or our planned clinical trials for other indications using the PoNS device may fail to demonstrate the safety and efficacy of the PoNS device to the satisfaction of applicable regulatory authorities.
- We may be required to suspend or discontinue clinical trials due to side effects or other safety risks that could preclude approval of our products.
- If we are unable to obtain coverage or adequate reimbursement for our products, use of our products may decline and our ability to generate revenue may be decreased.
- If we fail to comply with healthcare laws, we could face substantial penalties and financial exposure, and our business, operations and financial condition could be adversely affected.
- Our communications regarding products and product candidates, even while in development, are subject to extensive government scrutiny. We may be subject to governmental, regulatory and other legal proceedings relative to advertising, promotion, and marketing, and communications with study subjects and healthcare professionals, which could have a significant negative effect on our business.
- Even after marketing authorization and/or certification for our product is obtained, we are subject to extensive post-market regulation by the FDA and equivalent foreign competent authorities. Our failure to meet strict regulatory requirements could require us to pay fines, incur other costs or even close our facilities.
- After commercialization, our products may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us. The FDA and similar foreign governmental authorities such as the competent authorities of the European Economic Area countries or Health Canada have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture or in the event that a product poses an unacceptable risk to health. Manufacturers may, under their own initiative, recall a product if any material deficiencies in our products are found. A government-mandated or voluntary recall by us could occur as a result of an unacceptable risk to health, component failures, manufacturing errors, design or labeling defects or other deficiencies and issues.
- U.S. legislative or FDA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of our product and to manufacture, market and distribute our products after marketing authorization is obtained.
- If our expenses are greater than anticipated, then we will have fewer funds with which to pursue our plan of operations and our financing requirements will be greater than anticipated.
- Our ability to use net operating losses to offset future taxable income may be subject to certain limitations.
- As a result of the use of our product in clinical trials, and through the sale of our products, we may be liable for product liability claims and we may not carry sufficient product liability insurance.
- We are a “smaller reporting company” under federal securities laws and we cannot be certain whether the reduced reporting requirements applicable to such companies will make our common stock less attractive to investors.
- Investors could lose confidence in our financial reports, and the value of our common stock may be adversely affected, if our internal controls over financial reporting are found not to be effective by management or by our independent registered public accounting firm.
- Several people who work for us on a part-time consulting basis may be subject to conflicts of interest.
- Our business and operations would suffer in the event of computer system failures, cyber-attacks or a deficiency in our cyber-security.
- We could be delisted from The Nasdaq Capital Market, which could seriously harm the liquidity of our stock and our ability to raise capital.
- An active trading market for our common stock on The Nasdaq Capital Market may not continue to develop or be sustained.
- Trading of our common stock could be sporadic, and the price of our common stock may be volatile; we caution you as to the highly illiquid nature of an investment in our shares.
- Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result.
- Our certificate of incorporation provides that the Court of Chancery of the State of Delaware and, to the extent enforceable, the federal district courts of the United States of America will be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
- If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline.
- We have not paid any dividends and do not foresee paying dividends in the future.
- A decline in the price of our common stock could affect our ability to raise any required working capital and adversely affect our operations.
- We are heavily dependent upon the ability and expertise of our management team and a very limited number of employees and the loss of such individuals could have a material adverse effect on our business, operating results or financial condition.