TELA Bio, Inc.

We believe that our current facilities meet our current and future anticipated needs, although we may seek to negotiate new leases or evaluate additional or alternate space for our operations. We believe appropriate office space will be readily available on commercially reasonable terms.

• The misuse or off-label use of our products may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of our products for these uses.
• If we are unable to achieve and maintain adequate levels of coverage or reimbursement for our OviTex, OviTex PRS or other products we may commercialize in the future, our commercial success may be hindered.
• If competitors enter into supply contracts with our customers that disfavor our products or discourage their use, our commercial success could be adversely affected.
• Our long-term growth may depend on our ability to enhance our product offerings.
• In the future our products may become obsolete, which would negatively affect operations and financial condition.
• To successfully market and sell our products in markets outside of the U.S., we must address many international business risks with which we have limited experience.
• Risks Related to Our Reliance on Third Parties
• We are highly dependent upon Aroa, as the exclusive manufacturer and supplier of our OviTex and OviTex PRS products.
• We, or our partners, may experience development or manufacturing problems, capacity constraints, disruptions or delays in the production of our products that could limit the potential growth of our revenue or increase our losses.
• Our products contain materials derived from animal sources and may become subject to additional regulation.
• Our supply of ovine rumen for use in manufacturing our products may be vulnerable to disruption due to natural disaster, disease or other events.
• Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business and harm our reputation and ability to provide our products on a timely basis.
• Risks Related to Intellectual Property Matters
• 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.
• If we fail to comply with our obligations under any license, collaboration or other agreements, we could lose intellectual property rights that are necessary for developing and protecting our products.
• If we are unable to adequately protect our intellectual property rights, or if we are accused of infringing on the intellectual property rights of others, our competitive position could be harmed or we could be required to incur significant expenses to enforce or defend our rights.
• Patents covering our products could be found invalid or unenforceable if challenged in court or before administrative bodies in the U.S. or abroad.
• Third parties may assert ownership or commercial rights to inventions we develop.
• Litigation or other proceedings or third-party claims of intellectual property infringement could require us to spend significant time and money, enter into license agreements for disputed intellectual property and could prevent us from selling our products.
• If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be harmed.
• If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest.
• We may be unable to enforce our intellectual property rights throughout the world.
• Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
• Recent changes in U.S. patent laws may limit our ability to obtain, defend and/or enforce our patents.
• Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
• Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
• We may be unable to obtain a patent term extension in the U.S. under the Hatch-Waxman Act and in foreign countries under similar legislation.
• Intellectual property rights do not necessarily address all potential threats.
• Risks Related to Government Regulation
• Our products and operations are subject to extensive government regulation and oversight both in the U.S. and internationally.
• We may not receive, or may be significantly delayed in receiving, the necessary clearances or approvals for our future products and modifications to our current products may require new 510(k) clearances or PMA approvals, and may require us to cease marketing or recall the modified products until clearances or approvals are obtained.
• Although we have obtained regulatory clearance for our products, they will remain subject to extensive regulatory scrutiny.
• Our products must be manufactured in accordance with federal and state regulations, and we could be forced to recall our products or terminate production if we fail to comply with these regulations.
• If guidelines for soft-tissue reconstruction surgery change or the standard of care evolves, we may need to redesign and seek new marketing authorization from the FDA for our OviTex, OviTex PRS products or other products we may commercialize in the future.
• Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearances or approvals for our products or to manufacture, market or distribute our products after clearance or approval is obtained.
• Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates.
• Changes in funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner.
• The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.
• Our relationships with surgeons, patients and payors in the U.S. are subject to applicable anti-kickback, fraud and abuse laws and regulations.
• We are subject to anti-bribery, anti-corruption, and anti-money laundering laws, including the U.S. Foreign Corrupt Practices Act, in which violations of these laws could result in substantial penalties and prosecution.
• Our use of new and evolving technologies, such as artificial intelligence, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
• We face risks related to our collection and use of data, which could result in investigations, inquiries, litigation, fines, legislative and regulatory action and negative press about our privacy and data protection practices.
• The Affordable Care Act and any changes in healthcare law may increase the difficulty and cost for us to successfully commercialize our products and affect the prices we may obtain.
• Our business involves the use of hazardous materials and we and Aroa must comply with environmental laws and regulations, which may be expensive and restrict how we do business.
• Our business may be impacted by political, trade or regulatory developments in the jurisdictions in which we sell our products.
• Risks Related to Our Business and Products
• Our financial results may fluctuate significantly and may not fully reflect the underlying performance of our business.
• We may be unable to compete successfully with larger competitors in our highly competitive industry.
• We may be unable to renew existing contracts with GPOs or obtain additional contract positions with major GPOs and IDNs, for our products, and even if we are able to do so, such contracts may not generate sufficient sales of our products.
• Supply chain disruptions could adversely impact our operations and financial condition.
• We face the risk of product liability claims that could be expensive, divert management’s attention and harm our reputation and business.
• The continuing development of our products depends upon our maintaining strong working relationships with surgeons.
• We have limited data and experience regarding the safety and efficacy of certain of our products. Results of earlier studies may not be predictive of future clinical trial results, or the safety or efficacy profile for such products.
• Interim “top-line” or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
• The sizes of the markets for our current and future products have not been established with precision, and may be smaller than we estimate.
• Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventory.
• We rely on our own direct sales force for our products, which may result in higher fixed costs than our competitors and may slow our ability to reduce costs.
• Our employees, independent contractors, consultants, commercial partners, distributors and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
• We could be adversely affected by any interruption to our ability to conduct business at our current location.
• If we or our vendors experience a cybersecurity incident, significant disruption or a compromise of our information technology systems, our business could be adversely affected.
• If we become profitable, our ability to use our net operating loss carryforwards and other tax attributes to offset future taxable income or taxes may be subject to limitations.
• Risks Related to Our Securities
• The trading price of the shares of our common stock has been and could in the future be highly volatile.
• If we fail to comply or regain compliance with the continued listing standards of Nasdaq we may be delisted and the price of our common stock, or ability to access the capital markets and our financial condition could be negatively impacted.
• We do not intend to pay cash dividends on our common stock for the foreseeable future.
• Our directors, officers and principal stockholders have significant voting power and may take actions that may not be in the best interests of our other stockholders.
• We are at risk of securities class action litigation.
• If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.