Polaris Inc.

Lyndra is advancing a pipeline of long-acting pills spanning several therapeutic areas. Lyndra Therapeutics is laying off roughly 23% of its staff, two months after the company swapped out longtime CEO Patricia Hurter, Ph.D., and as a pivotal trial for a long-acting, oral schizophrenia drug nears an interim readout. The cuts come after the company's recent decisions to outsource commercial manufacturing and partner on both the development and commercialization of "all future products," a spokesperson said Friday. The company is also leaving its headquarters in Watertown, Massachusetts, and is consolidating at a nearby location in Lexington. "With our topline data readout from our pivotal trial of oral weekly risperidone expected in the next few weeks, we feel these changes will set us up to successfully navigate the regulatory pathway ahead and ultimately bring oral weekly medications to patients," the spokesperson said. The company plans to partner up on lead asset LYN-005, though a collaborator has not been disclosed or named, the spokesperson said. Lyndra's core business is a drug delivery platform spun out of MIT that aims to significantly reduce the dosing frequency required for oral pills. LYN-005 is a longer-acting version of schizophrenia medicine Risperdal, originally developed by Johnson & Johnson. A phase 3 trial for the pill started in March and is looking to enroll 90 patients. A long-acting injectable version of the approved drug, Uzedy, was at the center of a marketing scandal ten years ago after J&J pled guilty to a criminal misdemeanor charge of improperly marketing the product to older adults for unapproved uses. Federal prosecutors also alleged that the company falsely marketed the product to younger children and people with developmental disabilities. Lyndra hopes to boost the drug's duration and reclaim its reputation in the process. The biotech’s clinical progress comes as Karuna Therapeutics gears up for approval of its own, novel schizophrenia drug called KarXT. Recent phase 3 results showed that patients on the treatment experienced an 8.4% reduction on the Positive and Negative Syndrome Scale, a measure of schizophrenia symptoms. The drug seemingly performed better at reducing “positive” symptoms, such as hallucinations, versus “negative” symptoms, like feeling withdrawn from the world. Karuna’s application is expected any day after the company estimated it would formally submit a package to the FDA in the third quarter of the year. As for Lyndra, the company in July replaced CEO Patricia Hurter with chief operations officer Jessica Ballinger. The company also announced that chief medical officer Richard Scranton, M.D., would gain the additional title of president of global product development. Ballinger said at the time that Lyndra had a “clear line of sight to NDA filing” for LYN-005. Lyndra is also working on a long-acting version of another antipsychotic, Abilify, though that candidate remains in the preclinical stage. Elsewhere, the company has two phase 1-stage candidates for diabetes med Farxiga and Crestor. The company's platform has drawn interest from the Bill and Melinda Gates Foundation, which is helping fund trials of a long-acting version of malaria pill ivermectin in addition to a long-acting, once-a-month, oral contraceptive, LYN-064. Lyndra is also working on long-acting alternatives for opioid use disorder treatments in partnership with the National Institutes of Health. The company’s last round of fundraising came in June 2021 when it bagged nearly $61 million. The fundraising round was supported by Gilead Sciences, Polaris and AIG Investments, among others. Editor's note: This story was updated to clarify that Uzedy was a long-acting, injectable version of Risperdal. Both were developed by J&J.

Given that Medicaid and CHIP cover a significant portion of all pregnancies in America—especially for historically disadvantaged groups—policy actions could play a key role in supporting vaccine access and health equity. As public health officials nationwide sound the alarm on a “tripledemic”—the emergence of the respiratory syncytial virus (RSV), the influenza virus and the COVID-19 virus simultaneously—pregnant women should take steps to protect themselves and their infants against infection. While cases of RSV in particular continue to climb, a new prenatal vaccine can reduce the risk of RSV-caused hospitalization by 60% if taken during the third trimester of pregnancy. However, during the 2022 flu season, only one out of four pregnant women received the prenatal vaccines recommended by the Centers for Disease Control and Prevention.   There are also troubling disparities in vaccination rates. Pregnant women with private health insurance are 74% more likely to receive recommended prenatal vaccines than pregnant women covered by Medicaid and the Children’s Health Insurance Program (CHIP), which provide healthcare coverage for low- and middle-income populations. This is a significant health equity issue: Medicaid and CHIP cover more than four out of 10 of all births in America (PDF), and approximately seven out of 10 births for pregnant women who are Black, American Indian, or Alaska Native—groups that experience severe and persistent disparities in maternal and infant outcomes. Improving vaccination rates in Medicaid will help improve vaccination rates for historically underrepresented groups. Making it easier for pregnant women to access vaccines—such as during a regular prenatal visit or at a community pharmacy—is one way to enhance vaccine uptake. Below, we recommend changes states can make to their Medicaid and CHIP policies to support access to prenatal vaccines in these settings. Our recommendations are informed by a recent study of Medicaid and CHIP policies in all 50 states, plus Washington, D.C., and Puerto Rico. The study was conducted by Manatt Health and supported by Pfizer, which manufactures prenatal and other vaccines (Editor’s note: Pfister and Polaris are co-authors of the white paper study.) Ensure adequate reimbursement for administering prenatal vaccines   First, states should ensure that physicians and other providers who administer prenatal vaccines receive adequate reimbursement. Providers incur a range of costs to acquire, store and administer vaccines, but state Medicaid programs don’t always adequately reimburse for these costs. The Manatt study found that many state Medicaid programs pay physicians less for the vaccines themselves than Medicare does.  In addition, most state Medicaid programs pay less than half the Medicare rate for adult vaccine administration, including nine that don’t pay a vaccine administration fee at all. As a result, in some states, Medicaid providers lose money (PDF) with every shot they administer. Evidence (PDF) shows that vaccine access for Medicaid beneficiaries improves when states close the reimbursement gap between Medicaid and other payers. Ensure pharmacies are properly incentivized to offer prenatal vaccines   Second, states should ensure that their Medicaid policies encourage pharmacies to offer prenatal vaccines.  As compared to physician offices, community pharmacies are located in more places and are more likely to be open outside regular business hours.  In addition, unlike most physician offices, community pharmacies generally offer vaccines on a walk-in basis. Unfortunately, the Manatt study found that in some states, pharmacists aren’t eligible to bill Medicaid for certain vaccines. And even when they are, states vary widely in their payment rates for pharmacist vaccinations. Ensuring that pharmacists are eligible to bill Medicaid for vaccines and that they are adequately reimbursed for doing so would help increase vaccine access. Ensure that the Vaccines for Children (VFC) program does not create barriers to vaccinations for pregnant youth   Third, states should make it easier to access vaccines through the federal VFC program. The VFC program distributes vaccines free of charge to state-certified providers for administration to youth enrolled in Medicaid (among others). In some states, only VFC providers are eligible to bill Medicaid for administering pediatric vaccines. However, compared to pediatricians, OB-GYNs and pharmacies are less likely to participate in VFC because of the administrative costs of participation, their relatively low volume of pediatric vaccines and states’ relatively low reimbursement for vaccinations. Given that four out of five (PDF) pregnant adolescents are covered by Medicaid, states should consider allowing OB-GYNs and pharmacies to bill for prenatal vaccines without enrolling in the VFC program, thereby enabling pregnant adolescents convenient access to those vaccines during their prenatal visits or at a pharmacy. Leverage managed care organizations   Fourth, states should consider opportunities to leverage managed care organizations—private health plans that contract with states to administer coverage and that now cover the vast majority of non-elderly Medicaid and CHIP enrollees. States can direct managed care plans to provide appropriate reimbursement for both vaccines and vaccine administration, as described above. In addition, states can require managed care plans to conduct member outreach and education on prenatal vaccines as part of care coordination for pregnant enrollees and can also define quality measures and financial incentives for their plans related to prenatal vaccination outreach and uptake. Address vaccine hesitancy   Finally, although we focus here on vaccine access, we should also be mindful that some individuals have concerns or uncertainty about receiving vaccines (prenatal or otherwise). Research shows that prenatal vaccine hesitancy reflects a combination of factors such as lack of healthcare access, cultural attitudes and beliefs, health literacy, trust in healthcare providers and racial discrimination. Thus, states should pair the access-focused strategies above with strategies to support public awareness and education regarding prenatal vaccinations, including local public service announcements as well as targeted and culturally competent outreach. Prenatal vaccines play a vital role in promoting healthy pregnancies and healthy babies. Given that Medicaid and CHIP cover a significant portion of all pregnancies in America—especially for historically disadvantaged groups—the policy actions described above could play a key role in supporting vaccine access and health equity. Elizabeth Cherot, M.D. is president and CEO of March of Dimes. Helen Pfister and Julian Polaris are partners in Manatt Health, the legal and consulting healthcare group of professional services firm Manatt, Phelps & Phillips, LLP. 

STELLAR Knee ushers in a new era of mixed-reality total joint arthroplasty MIAMI--(BUSINESS WIRE)-- PolarisAR, a developer of advanced mixed-reality surgical guidance technology, announced the first total knee arthroplasty (TKA) using its STELLAR Knee mixed-reality surgical guidance system. This press release features multimedia. View the full release here: The world's first total knee arthroplasty (TKA) was performed using the breakthrough STELLAR Knee mixed-reality surgical guidance system from PolarisAR. (Photo: Business Wire) The procedure was performed at New York-Presbyterian/Columbia University Irving Medical Center in New York. STELLAR Knee is a mixed-reality surgical navigation platform that guides TKA procedures by displaying measured and computed data overlaid directly in a 3D environment. The mixed-reality system acts as a spatial computer, creating continuous data exchange between the surgeon and the software to help enhance surgical decision-making while simplifying operating room workflow. “STELLAR Knee represents a paradigm shift in the OR, as we aim to offer surgeons robot-like precision and real-time guidance throughout TKA procedures,” said Paul Mikus, CEO of PolarisAR. “STELLAR Knee also fills a crucial gap in hospitals where existing robotic systems may already be in use. By seamlessly integrating into surgical workflows and delivering comparable precision in a mixed reality format, STELLAR Knee ensures that every patient can now access the highest standard of care.” The U.S. Food & Drug Administration (FDA) cleared the STELLAR Knee mixed-reality surgical guidance system in November 2023 for use in TKA procedures. The STELLAR Knee system is designed to offer precise control over intraoperative variables compared to traditional instruments, navigation systems, and first-generation augmented reality. Through meticulous measurement, planning and guidance, it enables surgeons to optimize lower limb alignment, soft tissue balance, joint line maintenance and component positioning. Over the next coming several weeks, STELLAR Knee’s commercial launch will continue at leading institutions throughout the U.S. Traditional techniques for TKA have long been associated with various challenges and limitations. Surgeons often face difficulties in achieving precise alignment and balance of the lower limb. Additionally, closed implant systems and preoperative imaging methods may restrict flexibility and customization, limiting the surgeon's ability to tailor the procedure to individual patient needs. In addition, traditional robotic technologies, with their large intraoperative footprint, can present barriers to widespread adoption. By contrast, Stellar Knee is agnostic to implant and imageless, making it more accessible to surgeons. The democratization of enabling technologies is a key objective for PolarisAR. About PolarisAR PolarisAR is a privately held startup based in Miami, founded in 2020. The company is developing a new class of mixed-reality surgical technology designed to optimize intraoperative workflows and improve patient outcomes using advanced, three-dimensional spatial computing algorithms. Its first product is the STELLAR Knee mixed-reality surgical guidance system, cleared by the FDA in 2023 for total knee arthroplasty (TKA) procedures. STELLAR Knee offers a mixed-reality platform that comprehensively assesses bony anatomy and soft tissue to ensure precise extension and flexion gap resections. By combining the benefits of robot-like precision with the simplicity of a mixed-reality headset, Polaris aims to transform the landscape of orthopedic surgery. More information may be found at .