Content analysis
?Positive | ||
Negative | ||
Uncertain | ||
Constraining | ||
Legalese | ||
Litigous | ||
Readability |
H.S. junior Avg
|
New words:
absorption, accretion, AcGuide, actuated, allotted, Andrew, angle, appendage, arisen, atrium, begun, Bonita, capture, Chapter, Charlie, chronic, climate, conclusion, cumbersome, cut, David, deep, deliverability, departure, depth, diameter, disaggregated, diversification, duly, easily, effectuate, ElBardissi, Exhibit, exhibited, explore, exploring, extraordinary, fewer, flooding, floor, footprint, foster, Garland, gave, Gaza, guidewire, heat, hereof, herewith, hollow, hub, hundred, hypothetical, incident, incidental, inflationary, intensified, Interactive, interatrial, investee, Israel, issuable, iXBRL, Jason, Kevin, language, Larger, lawfully, LDA, leadership, leaky, Linkbase, lock, Marzouk, matched, mitral, MSA, Mukai, noncash, numerator, objection, omit, omitted, ourself, outflow, page, paragraph, partner, passage, Piscitello, predetermined, proactive, qualification, quantified, ratifying, reallocate, recapitalize, Recoupment, refinance, regurgitation, reliant, remote, reorganization, reposition, repudiation, repurchase, resale, Rescission, resubstitution, Roman, salesperson, salvage, Schema, sea, septum, Shaden, shelf, signature, smooth, Sohn, stead, stream, Takeo, taxonomy, thereunto, therewith, thousand, timetable, Tom, transcatheter, tribunal, undersigned, undetected, unintended, untrue, upkeep, valve, vandalism, Vice, vigorously, wider, wire, withholding, wound, XBRL
Removed:
abandon, abbreviated, abide, ablate, ablated, absence, absent, accelerate, accessory, Accountability, ad, adding, addressed, adherence, adhering, administered, adulterated, adulteration, advancing, advertised, advertising, advice, afford, Affordable, agree, agreeing, Aid, aim, allegation, alliance, Alternatively, altogether, amortizable, analytical, analyze, anatomically, animal, anticipation, applicant, approvability, approvable, arranging, array, arsenal, art, assembled, attack, attain, attraction, authorizing, awarded, aware, back, BBA, belief, beneficiary, bidding, bind, BioConcept, biomedical, biometric, biopotential, Bipartisan, blocking, bore, borrowed, bound, Brexit, bribery, bringing, Britain, broaden, broadly, Budget, budgeted, build, bundled, bundling, called, cancellation, candidate, capable, category, CCPA, Certificat, certified, certiorari, chamber, channel, charitable, Children, Circuit, circumvent, clarification, clinically, clock, close, CMS, coding, cold, collaborative, commenced, commercialized, commercializing, Commissioner, committing, comparative, compelled, compelling, complicated, complicating, compromised, compulsory, conceal, concealing, concentrated, conclude, Concurrently, conduction, conflicting, conformance, confusion, congestion, Congressional, connected, connectivity, considerable, consistently, constitute, constrain, construe, consumed, consummated, consummating, contacting, content, contest, context, continuation, contracted, contracting, convened, converted, cooperate, cooperative, Cosmetic, counter, covertly, CPRA, creation, cumulative, customize, cycle, Czech, de, dedicate, deeper, defraud, demanding, demonstrated, demonstrating, denial, Denmark, denominated, density, depository, derivation, derive, desirable, desired, deviate, deviating, devise, devote, diagnose, diagnosed, differentiate, differentiator, diligence, diligently, dilute, dilution, diminish, directed, disagreeing, disagreement, discovered, discovery, disproportionately, distinguish, diverse, diversify, dock, DOJ, dollar, domestic, domestically, donut, downgrade, drawn, dropping, durable, dynamic, education, educational, efficiently, effort, eligibility, embodying, emerge, empowered, enabled, encountered, encourage, enhancement, enhancing, enjoined, enroll, enrolled, enrolling, entrance, equivalence, establishment, EU, evolved, examiner, exceeding, exclusivity, exempt, expanding, expansion, expansive, expend, expenditure, expertise, exported, exporting, extend, extraterritorially, faculty, failed, falling, falsifying, family, FCPA, FDCA, feasible, Finally, fine, fit, flutter, format, formation, formulate, France, Frankfurt, freedom, frequency, FTC, function, functionality, fundamental, funded, furnishing, gap, GDPR, generational, generic, genetic, geographically, geography, globally, goal, GPO, Great, greatest, grow, half, Hampshire, heartbeat, hedge, hinder, HIPAA, hired, hiring, HITECH, hoc, hole, huge, identity, IDN, image, immigration, impacting, impairing, impeded, implantable, Importantly, improperly, improving, inaccurate, incentivize, inclement, inconclusive, inconsistent, incurrence, India, induce, ineffective, influencing, informally, informed, infringer, initiation, initiative, innovate, innovative, inspect, Inspector, instill, Institute, instituting, insufficient, integrate, integrating, inter, interference, interpret, interpretation, interpreted, interrupt, interspersed, introduce, invalid, invalidated, invention, investigate, investigated, investigating, investigator, IRB, irrigated, irrigation, Italy, iteratively, jeopardized, jeopardizing, Judge, jurisdictional, Justice, kind, Kingdom, knowingly, labeled, lag, landmark, laundering, leveraging, liable, LIBOR, literature, load, localized, low, lowering, mandate, mandatory, marked, mechanism, MedFact, misbranding, mission, mix, modification, move, movement, narrow, narrowed, narrowly, navigation, navigational, Nebraska, necessarily, negotiated, negotiation, Nevada, newly, nonclinical, noncompetitive, nondisclosure, novelty, nurse, NV, observe, offense, offload, OIG, oppose, opposition, optimizing, oral, ordering, organically, organized, outreach, outsourcing, oversee, overtly, panel, partially, participating, passionate, patentability, pattern, paused, payor, penetrating, permissible, permission, persistent, pertaining, petitioning, phase, pilot, pipeline, piracy, platform, play, Portability, post, postmarket, practicing, preapproval, preceding, preclinical, predicate, predicting, predominantly, premature, prescribe, prescribing, presenting, prevail, prioritize, produced, productive, profitably, progressed, prohibited, prohibitively, promising, promote, promoted, promoting, promotional, prompted, promulgated, prone, propagation, proposition, prosecuting, prospective, protocol, proving, provoke, provoked, publish, published, pursuit, put, qualifying, question, questioned, qui, radio, randomized, reach, reached, reaching, real, rebrand, recertification, recommended, recommending, recordkeeping, recourse, recruit, recruiting, recruitment, recurrence, redesign, redesigned, reexamination, referral, refuse, regime, regulating, reimbursed, rejection, reliably, relinquish, relocating, remanded, remeasurement, remedial, remedied, remedy, removing, remuneration, render, repayment, repealed, repeat, repetitive, representation, representative, requesting, reservation, reset, resignation, restrictive, restructured, reveal, revise, revocation, revoked, reward, RF, robotic, robust, round, RSA, ruled, ruling, safeguarding, salespeople, satisfactorily, scientifically, screen, searchable, sector, seeking, selection, sequence, sequentially, sequester, settled, settling, shared, sharper, Shield, shifting, shorten, shortened, shortly, show, shown, similarly, size, slower, solicited, soliciting, solution, sought, sound, source, spite, sponsor, sponsored, squarely, stable, STAR, statistical, statistically, strategically, strength, strict, stricter, strive, struck, studied, subjected, subscription, substantiate, substantiated, substantive, substituted, sufficiently, Sunshine, superiority, supplement, supraventricular, Supreme, surface, survive, susceptible, suspend, suspended, sustaining, Sweden, sweeping, switched, tachycardia, tam, tariff, taxation, Taxpayer, TCJA, teaching, terminable, therapeutic, tissue, today, tolerability, trademarking, train, transitioning, transmission, transport, travel, treated, trouble, Trump, typical, ultimately, ultrasound, unacceptable, unapproved, unclear, uncleared, unconstitutional, undergone, unduly, unenforceability, unfamiliar, unlimited, unmet, unpatented, unreasonable, unsatisfactory, unstable, upheld, variation, ventricular, view, viewed, violating, Virginia, visibility, visualization, VTs, weather, widely, willingly, world, writing
Financial report summary
?Risks
- The Restructuring has changed, and is expected to continue to significantly change, our business, and may result in disruption to our continuing business.
- We are dependent on our strategic relationship with Medtronic for all of our revenue, with no sales or marketing capabilities of our own, and the loss of this partner would completely eliminate our revenue. We currently depend on revenue generated from a single business line (manufacturing Medtronic’s left-heart access portfolio) and for the foreseeable future will be significantly dependent on a limited number of products.
- Our business is not diversified. If our sole business line is disrupted, our business and results of operations would be adversely affected.
- If our Distribution Agreement with Medtronic terminates upon the occurrence of the Second Closing or for any other reason, and following the conclusion of the Net Sales Earnout period, we will have no sources of revenue.
- There are continued risks associated with the Restructuring, including our ability to complete the wind down and to manage the associated Restructuring and transition costs to realize the anticipated benefits, the impact of the Restructuring on our relationships with our employees, our major customers, distributors and vendors and unanticipated expenses and charges that may be incurred as a result of the Restructuring, such as litigation risks, including litigation regarding contract termination and employment and workers’ compensation.
- Our ability to continue to have the liquidity necessary to service our debt, meet contractual payment obligations and fund our operations depends on many factors, including our ability to generate sufficient cash flow from operations or obtain other financing.
- If our Restructuring is not successful, our board of directors may decide to pursue a liquidation and dissolution of our business. In such an event, the amount of cash available for distribution to our stockholders, if any, will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities, including under our 2022 Credit Agreement.
- The commercial success of the Products, and thus our ability to generate revenue from Medtronic’s sales of the Products, will depend upon attaining significant market acceptance of the Products among hospitals, physicians, patients and payors.
- We operate in a highly competitive industry, and if we or the Products are unable to compete successfully, our sales to Medtronic may decline and our revenue from Medtronic’s sales of the Products to end-users may be reduced, and there would be a material adverse effect on our business and results of operations.
- Our quarterly and annual results may fluctuate significantly and may not fully reflect the underlying performance of our business.
- We depend upon third-party suppliers including single-source suppliers, making us vulnerable to supply disruptions and price fluctuations.
- Defects or failures associated with the Products could lead to recalls, safety alerts or litigation, as well as significant costs and negative publicity for our business.
- Our operations and financial results may be adversely impacted by the resurgence of COVID-19 or another global pandemic.
- We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability due to the ongoing military conflict between Russia and Ukraine and Israel and Hamas. Our business, financial condition and results of operations may be materially adversely affected by any negative impact on the global economy and capital markets resulting from the conflict in Ukraine or Gaza or any other geopolitical tensions.
- Inability to retain highly skilled employees, especially manufacturing employees, could harm our business.
- Changes to management, including turnover of our top executives, could have an adverse effect on our business.
- Our results of operations could be materially harmed if we are unable to accurately forecast Medtronic demand for the Products and manage our inventory.
- The failure of third parties to meet their contractual, regulatory and other obligations could adversely affect our business.
- The transfer pricing for our sale of Products to Medtronic under the Distribution Agreement may not be sufficient to cover our costs.
- If our facility becomes damaged or inoperable or if we are required to vacate a facility, we may be unable to manufacture the Products or we may experience delays in production or an increase in costs, which could adversely affect our results of operations.
- We have limited experience manufacturing the Products in commercial quantities, which could harm our business.
- Consolidation in the medical device industry could have an adverse effect on our revenue and results of operations.
- The sizes of the markets for the Products have not been established with precision and may be smaller than we estimate.
- The use, misuse or off-label use of the Products may result in injuries that lead to product liability suits, which could be costly to our business.
- The terms of our 2022 Credit Agreement, require us to meet certain operating and financial covenants and place restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.
- Taxing authorities may successfully assert that we should have collected or in the future should collect sales and use, gross receipts, value added or similar taxes and may successfully impose additional obligations on us, and any such assessments or obligations could adversely affect our business, financial condition and results of operations.
- Our ability to utilize our net operating loss carryforwards may be limited.
- If we experience significant disruptions in our information technology systems, our business may be adversely affected.
- Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
- Certain of our operating results and financial metrics may be difficult to predict as a result of seasonality.
- Climate-related events and other such similar events could harm our business.
- We historically had net losses, and our new business following the Restructuring may not be profitable or continue to generate any revenue.
- In order to support our continued operations, we need to raise additional capital, which will not likely be available to us on acceptable terms, or at all.
- Regulatory compliance is expensive, complex and uncertain, and failure to comply could lead to enforcement actions against us and other negative consequences for our business.
- Our operations are subject to pervasive and continuing FDA regulatory requirements.
- Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearance or approval of the Products and to manufacture and distribute the Products to Medtronic after clearance or approval is obtained.
- If we fail to comply with the FDA’s QSR, or other FDA or European Union requirements, the FDA or the competent European Union authority could take various enforcement actions including halting our manufacturing operations, and our business would suffer.
- The Products may be subject to recalls after receiving FDA or foreign approval or clearance, which could divert managerial and financial resources, harm our reputation and adversely affect our business.
- If any of the Products we manufacture cause or contribute to a death or a serious injury or malfunction in certain ways, we will be required to report under applicable MDR regulations, which can result in voluntary corrective actions or agency enforcement actions.
- Our strategic partner, employees, independent contractors, consultants, and vendors may engage in misconduct or other improper activities including noncompliance with regulatory standards and requirements.
- Compliance with environmental laws and regulations could be expensive, and failure to comply with these laws and regulations could subject us to significant liability.
- We are a contract manufacturer, and our lack of any meaningful registered intellectual property means we rely solely on our manufacturing processes for our success.
- We are required to indemnify Medtronic for intellectual property claims in respect of the Products under the Asset Purchase Agreement, and as a result we may become a party to intellectual property litigation or administrative proceedings that could be costly and could interfere with our ability to sell the Products to Medtronic and Medtronic’s ability to sell the Products to end-users.
- Our rights to develop, manufacture and distribute the Products to Medtronic are subject, in part, to the terms and conditions of licenses granted to us by Medtronic.
- If we are unable to protect the confidentiality of our other proprietary information covering the Products, our business and competitive position may be harmed.
- Maintaining patent protection for the Products depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and patent protection for the Products could be reduced or eliminated by Medtronic’s non-compliance with these requirements, which could have a material adverse effect on our business, financial condition and results of operations.
- We may be subject to claims that we or our employees, consultants or contractors have wrongfully used, disclosed or otherwise misappropriated the intellectual property of a third party, including trade secrets or know-how, or are in breach of non-competition or non-solicitation agreements with our competitors or claims asserting an ownership interest in intellectual property we regard as our own or otherwise transferred to Medtronic.
- We may be subject to claims challenging the inventorship of the patents we transferred to Medtronic and other intellectual property in respect of the Products.
- Our failure to maintain compliance with Nasdaq’s continued listing requirements would result in the delisting of our common stock.
- If our common stock is delisted from Nasdaq and is traded over-the-counter, your ability to trade and the market price of our shares of common stock may be negatively impacted.
- The market price for our common stock has been volatile, it may decline regardless of our operating performance, and an active trading market may not be sustained in our common stock.
- We are and will continue to be subject to securities litigation, which is expensive and could divert management attention.
- We currently do not intend to declare dividends on our common stock in the foreseeable future and, as a result, your only opportunity to achieve a return on your investment is if the price of our common stock appreciates.
- We are an emerging growth company and a smaller reporting company, and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to emerging growth companies and smaller reporting companies could make our common stock less attractive to investors.
- Our directors, executive officers and principal stockholders and their respective affiliates have substantial influence over us and could delay or prevent a change in corporate control; our principal stockholders may have interests that conflict with your interests as an investor in our common stock.
- Provisions in our organizational documents and agreements with third parties could delay or prevent a change of control.
- Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware and 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.
- Our board of directors is authorized to issue and designate shares of our preferred stock in additional series without stockholder approval.
- Our quarterly operating results fluctuate and may fall short of prior periods, our projections or the expectations of securities analysts or investors, which could materially adversely affect our stock price.
- Market conditions and changing circumstances, some of which may be beyond our control, could impair our ability to access our existing cash, cash equivalents and investments and to timely pay key vendors and others.
- Economic conditions may adversely affect our business.
- Litigation and other legal proceedings may adversely affect our business.
- The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain qualified board members.
Management Discussion
- Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
- Historically, we designed, manufactured and marketed a range of tools for catheter-based ablation procedures to treat various arrhythmias. Our product portfolio included novel access sheaths, diagnostic and mapping catheters, conventional and contact ablation catheters, mapping and imaging consoles and accessories, as well as supporting algorithms and software programs. Our foundational product was our AcQMap imaging and mapping system, which was designed to rapidly and accurately identify ablation targets and to confirm both ablation success and procedural completion.
- In April 2022, we announced that we agreed to sell our left-heart access product portfolio to Medtronic and refinance existing debt with a new longer-term credit facility to recapitalize our business and fund our strategic growth priorities. Pursuant to the sale transaction, Medtronic paid upfront cash consideration of $50.0 million (of which $4.0 million was paid into an indemnity escrow account for a period of 18 months), and we became eligible for contingent cash consideration of up to $37.0 million (of which we earned $20.0 million on October 31, 2022 and $17.0 million on December 31, 2022) plus a portion of Medtronic’s future net sales of the left-heart access product portfolio. In conjunction with the sale of our left-heart access product portfolio, we executed a Distribution Agreement with Medtronic, pursuant to which we agreed to manufacture and supply these left-heart access products to Medtronic as exclusive distributor of the product line for an initial term of up to four years at specified transfer prices. We will also continue to be eligible for earnout payments on Medtronic’s net sales of the left-heart access product portfolio through 2027.