OraPharma Launches OraFit™ Custom Clear Dental Aligner System

USA - English

• USA - English

LAVAL, QC, Feb. 22, 2022 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") and its oral health care business, OraPharma, today announced the U.S. launch of the OraFit™ custom clear aligner system, which is indicated for correcting malocclusion, which is also known as crooked or misaligned permanent teeth. The new OraFit™ aligner system uses high-performance materials in a three-layer design that offers dental professionals and their patients the latest in clear aligner technology and addresses the increased demand for improved aesthetics, more comfortable aligners and overall long-term oral health.¹

"Malocclusion is one of the most common dental problems, and it impacts approximately two out of three people in the United States³," said Joseph C. Papa, chairman and CEO, Bausch Health. "With the availability of OraFit™, dental professionals have a new custom aligner option that can easily fit into their patients' daily routines as it aligns their teeth into position with improved comfort due to the gentle, consistent pressure OraFit™ applies²."

Compared to many other aligners, the plastic material OraFit™ is made with has been proven to stay clearer longer and is highly crack-resistant¹. The OraFit™ system also includes an intuitive, user-friendly online resource that allows dental professionals to easily submit cases and approve treatment plans.

"Many of my patients with malocclusion are reluctant to use braces or aligners as a result of the impact they can have on their appearance," said David J. Wohl, DDS, PC, general dentist, Fairfield, Conn. "The clarity of OraFit™ may help to increase patient acceptance and compliance while also offering a meticulous fit. These benefits, along with the seamless integration that the online resource provides for my aligner wear protocols, has made OraFit™ a welcomed addition to my practice and to my patients."

Additionally, during the 2022 Chicago Dental Society Midwinter Meeting, which takes place Feb. 24-26, 2022, two presentations will feature OraPharma products, including:

• "Adjunctive Periodontal Therapy"
  Thursday, Feb. 24, 2022 at 9:30 a.m., 11 a.m., 1 p.m., 2:30 p.m. and 4 p.m. CT;
  Friday, Feb. 25, 2022 at 10:30 a.m., 12 p.m., 2 p.m., 3:30 p.m. and 5 p.m. CT; and Saturday, Feb. 26, 2022 at 9:30 a.m., 11 a.m. and 1 p.m. CT at McCormick Place West (2301 S. Lake Shore Drive, Chicago, in the OraPharma booth #5029)
  Timothy Donley, DDS, MDS, will discuss the state of periodontal disease (gum disease) in the 21^st century including risk factors, diagnosis guidelines and treatment options. This presentation will also discuss data on the efficacy and uses for OraPharma's treatment for periodontal disease, Arestin^®(minocycline HCI) Microspheres, 1mg.

• "General Dentistry Guide to Clear Aligners"
  Thursday, Feb. 24, 2022 from 10:30 – 11:30 a.m. CT and Saturday, Feb. 26, 2022 from 10:30 – 11:30 a.m. CT at McCormick Place West (2301 S. Lake Shore Drive, Chicago, in the Corporate Learning Theater)
  Dr. Wohl will lead a discussion on the state of the aligner market, including the oral benefits they offer, patient identification and the considerations clinicians should take when selecting aligners such as OraFit™.

For more information on the OraFit™ aligner system, visit www.myorafit.com.

About Malocclusion
Malocclusion typically occurs when teeth are either crowded, too large for the mouth or are crooked. This can also happen if the upper and lower jaws aren't aligned. Malocclusion is typically treated with orthodontics or braces, although more serious cases may require surgery. Aside from causing dental problems, such as tooth decay, losing teeth or developing gum disease, malocclusion can affect one's speech and impact how food is chewed⁴.

Indication and Important Safety Information for OraFit™

INDICATION:
The OraFit™ Custom Clear Aligner System is used for the straightening of crooked or misaligned permanent teeth through orthodontic treatment.

IMPORTANT SAFETY INFORMATION:
Do not use the OraFit™ Custom Clear Aligner System if you:

• Are allergic to plastics
• Have active periodontal disease

Precautions and Potential Risks

• Always follow the order and wear of your aligners as prescribed. Aligners worn out of sequence can result in delayed treatment and complications, including discomfort.
• Sensitivity and tenderness of your teeth may occur during treatment, especially when moving forward from one aligner step to the next.
• Aligner wear may temporarily affect your speech, resulting in a slight lisp. Patients typically adapt quickly to the aligners within a week or two.
• Extended treatment time may occur if you do not follow your doctor's instructions, wear aligners less than the prescribed hours, miss appointments, have poor oral hygiene, or use broken aligners.
• Irritation of the gums, cheeks, tongue, and lips may occur. Tell your doctor if you have any irritation that persists.
• The health of your gums and bone, both of which support your teeth, can be affected by wearing aligners.
• Your bite will change throughout the course of treatment and may result in temporary discomfort in your jaw joint. Although rare, you may experience joint pain, headaches or ear problems. You should let your doctor know if you experience any of these symptoms.
• At the end of treatment, it may be necessary for your doctor to make adjustments to your bite.
• Once your treatment has been completed, teeth may shift positions if proper and consistent wear of retainers is not followed.

THIS IS NOT ALL YOU NEED TO KNOW. Please ask your dentist if the OraFit™ Custom Clear Aligner System is right for you.

Important Safety Information for ARESTIN^®

INDICATION
ARESTIN^® (minocycline HCl) Microspheres, 1mg is used in combination with scaling and root planing (SRP) procedures to treat patients with adult periodontitis (gum disease). ARESTIN^® may be used as part of an overall oral health program that includes good brushing and flossing habits and SRP.

IMPORTANT SAFETY INFORMATION

• Do not take ARESTIN^® if you are allergic to minocycline or tetracyclines. Ask your dentist or pharmacist for a list of these drugs if you are not sure. Swelling of the face, itching of the skin, fever and enlarged lymph nodes have been reported with the use of ARESTIN^®. Some of these reactions were serious. Tell your dentist right away if you have any signs of allergic reaction, such as skin reactions or trouble breathing, or if you have an exaggerated sunburn reaction.
• THE USE OF TETRACYCLINE CLASS DRUGS, INCLUDING ARESTIN^®, DURING TOOTH DEVELOPMENT MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH, AND THEREFORE SHOULD NOT BE USED IN CHILDREN OR IN PREGNANT OR NURSING WOMEN.
• ARESTIN^® has not been studied in patients with weakened immune systems (such as patients with HIV infections or diabetes, or those receiving chemotherapy or radiation). Tetracyclines, including oral minocycline, have been associated with the development of autoimmune syndrome with symptoms such as joint pain, muscle pain, rash, swelling, fever, enlarged lymph nodes, and general body weakness. Tell your doctor about any health problems you have, including whether you have had oral candidiasis ("thrush") in the past, and about all medications you are taking.
• In clinical studies, the most frequently reported non-dental side effects were headache, infection, flu symptoms, and pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for full Prescribing Information.

About OraPharma
OraPharma is a specialty pharmaceutical company committed to partnering with dental professionals to improve oral health. Founded more than 25 years ago, OraPharma includes a curated portfolio of treatments for periodontal disease, malocclusion and multiple regenerative solutions for oral surgery. More information can be found at https://www.orapharma.com/.

About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.

Forward-looking Statements

This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, launches and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

References

1. Zendura XL Design Verification Report- Stain Resistance #18-05 Rev1 (v0.1)
2. Zendura Dental (2022). Zendura FLX Properties. Accessed Feb. 16, 2022. https://www.zenduradental.com/pages/zendura-flx-properties
3. Neely ML, Miller R, Rich SE, Will LA, Wright WG, Jones JA Effect of malocclusion on adults seeing orthodontic treatment
4. Cleveland Clinic (2022). Malocclusion. Retrieved from https://my.clevelandclinic.org/health/diseases/22010-malocclusion. Accessed Feb. 7, 2022.

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SOURCE Bausch Health Companies Inc.