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New words:
Angie, Aravt, Arena, Asia, aware, baseball, bond, Bronx, Businessman, chairperson, charitable, COBRA, college, column, conflict, converging, Cooperation, Cormier, CTO, Curry, Dartmouth, deep, Dell, DHI, Digikey, EDGAR, edition, Ensysce, enterprise, escalate, expertise, Fame, Football, Foundation, founder, franchise, Fundstrat, Geeknet, handling, Harper, identification, Inquiring, intelligence, intermediate, IRC, ISO, Israeli, journalist, Language, League, Liebowitz, Lucille, lump, Maven, meant, membership, mobile, Moscow, mother, NBA, Notably, Nuclear, peak, phased, phasing, pivotal, pledged, podcast, Port, premature, prescription, pro, proactive, prorated, ranked, rata, ratably, Realty, reappointed, reappointment, recover, recovered, Recovery, Renae, revoking, Rugby, Russia, Shaquille, Sonya, spite, stage, streamline, streamlining, strong, taxpayer, TCJA, TCS, telecom, timeframe, Tracy, TV, unlock, uptake, War, Westlake, wife, William, Xueda, youth
Removed:
achievable, advocacy, Apollo, applying, Arthur, Auditing, authored, background, Bay, Berkeley, Biology, BioMarin, bipartisan, centered, collaborated, Conger, Controller, coordinated, County, Covidien, creation, deal, demonstration, deployed, digitally, directed, distancing, Drexel, DTD, duration, East, eighteen, electronic, enrollment, evolve, forfeited, freestanding, Genentech, half, Hart, Hill, house, Humboldt, initiate, installed, Jose, leadership, Leibowitz, LLP, lobbying, manager, mandating, Master, MBA, Medicologic, medium, Mt, nation, navigate, OMB, oversee, pediatric, Pennsylvania, pharmaceutical, programmatic, qualifying, reached, reconsider, reevaluate, reexamining, regionally, remedied, running, Salusive, School, Secretary, Sinai, situation, sized, South, spread, standalone, subsidiary, successively, Teleperformance, Temple, temporary, weight, Wharton, wholly, windfall
Financial report summary
?Risks
- If we do not successfully implement our business strategy, our business and results of operations will be adversely affected.
- We predominantly market only one FDA-cleared vascular testing product; it may not achieve broad market acceptance or be commercially successful. We may also fail to generate meaningful revenues from our Insulin Insights distribution arrangement, which includes prepaid licenses, or benefit from our recent investments in other companies developing complementary products.
- Physicians and other customers may not widely adopt our products unless they determine, based on experience, long-term clinical data and published peer reviewed journal articles, that the use of our products provides a safe and effective alternative to other existing ABI devices.
- If healthcare providers are unable to obtain adequate coverage and reimbursement either for procedures performed using our product or patient care incorporating the use of our product, it is unlikely that our product will gain widespread acceptance.
- QuantaFlo is generally but not specifically approved for reimbursement under any third-party payor codes; if third-party payors refuse to reimburse our customers for their use of our product, it could have a material adverse effect on our business.
- We rely on a small number of employees in our direct sales force and face challenges and risk in managing and maintaining our distribution network and the parties who make up that network.
- To adequately commercialize our products and any new products we add, we may need to increase our sales and marketing network, which will require us to hire, train, retain and supervise employees and other independent contractors.
- We do not require our customers to enter into long-term licenses or maintenance contracts for our products or services and may therefore lose customers on short notice.
- We rely on a small number of independent suppliers and facilities for the manufacturing of QuantaFlo. Any delay or disruption in the supply of the product or facility may negatively impact our operations.
- We will need to generate significant revenues to remain profitable.
- Our future financial performance will depend in part on the successful improvements and software updates to QuantaFlo on a cost-effective basis.
- One of our business strategies is developing additional products and service offerings that allow healthcare providers to deliver cost-effective wellness programs and receive increased compensation for their services. The development of new products and service offerings involves time and expense and we may never realize the benefits of this investment.
- Our business is subject to many laws and government regulations governing the manufacture and sale of medical devices, including the FDA’s 510(k) clearance process, and laws and regulations governing patient data and information, among others.
- The FDA may change its policies, adopt additional regulations, or revise existing regulations, in particular relating to the 510(k) clearance process.
- Our business is subject to unannounced inspections by FDA to determine our compliance with FDA requirements.
- We may rely on third parties to support certain aspects of our clinical trials and regulatory processes. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory clearance or approval or commercialize our products, and our business could be substantially harmed.
- If we are found to have improperly promoted our products for off-label uses, we may become subject to significant fines and other liability.
- Although part of our business strategy is based on payment provisions enacted under government healthcare reform, we also face significant uncertainty in the industry regarding the implementation, transformation or repeal and replacement of the Health Care Reform Law.
- The applicable healthcare fraud and abuse laws and regulations, along with the increased enforcement environment, may lead to an enforcement action targeting us, which could adversely affect our business.
- Our ability to use NOL, carryforwards to offset future taxable income may be subject to limitations.
- We have had material weaknesses in our internal control over financial reporting. Although we have remediated our prior material weaknesses, if we identify additional material weaknesses in the future, or if our former material weaknesses recur, it could have an adverse effect on our company.
- Our success largely depends on our ability to obtain and protect the proprietary information on which we base our product.
- We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
- We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- Our executive officers, directors and significant stockholders, if they choose to act together, have the ability to substantially influence the outcome of all matters submitted to stockholders for approval.
- Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
- The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
- Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
- Because we operate in an industry with significant product liability risk, and we may not be sufficiently insured against this risk, we may be subject to substantial claims against our product or services that we may provide.
- We may implement a product recall or voluntary market withdrawal or stop shipment of our product due to product defects or product enhancements and modifications, which would significantly increase our costs.
- If we fail to properly manage our anticipated growth, our business could suffer.
- An information security incident, including a cybersecurity breach, could have a negative impact on our business or reputation.
- Fluctuations in insurance cost and availability could adversely affect our profitability or our risk management profile.
- We operate in an intensely competitive and rapidly changing business environment, and there is a substantial risk our products or service offerings could become obsolete or uncompetitive.
- Changes in, or interpretations of, tax rules and regulations may adversely affect our effective tax rates.
- You may experience future dilution as a result of future equity offerings.
Management Discussion
- ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION
- We are a company providing technology solutions to improve the clinical effectiveness and efficiency of healthcare providers. Our mission is to develop, manufacture and market innovative proprietary products and services that assist our customers in evaluating and treating chronic diseases. Our patented and FDA cleared product, QuantaFlo measures arterial blood flow in the extremities to aid in the diagnosis of PAD.
- We are currently seeking a new 510(k) clearance from the FDA for the expanded use of QuantaFlo, which is intended to enable expanded labeling as an aid in the diagnosis of other cardiovascular diseases in addition to PAD. We continue to develop additional complementary proprietary products in-house and seek out other arrangements for additional products and services that we believe will bring value to our customers and to our company. We believe our current products and services, and any future products or services that we may offer, position us to provide valuable information to our customer base, which in turn permits them to better guide patient care.