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PolarityTE, Inc. (Nasdaq: PTE) has submitted an Investigational New Drug (IND) application to the FDA for its SkinTE product, aimed at treating chronic cutaneous ulcers. The IND includes data from prior clinical use of SkinTE between 2017-2021 and multiple clinical trials. The company suggests preliminary evidence indicates SkinTE could significantly improve conditions stemming from chronic ulcers. PolarityTE anticipates FDA feedback within 30 days, which could lead to an accepted IND or require additional information. This submission marks a critical step towards a Biologic License Application.
PolarityTE, Inc. (Nasdaq: PTE) issued a statement addressing confusion among investors regarding its stock and the unrelated cryptocurrency Peet DeFi, which is often associated with the abbreviation ‘PTE coins’. The company is taking steps to clarify this misunderstanding, which may have impacted its stock trading activity. PolarityTE focuses on developing regenerative tissue products from patients' own tissues, with products like SkinTE currently in development and not approved for clinical use.
PolarityTE, Inc. (Nasdaq: PTE) announced the allowance of a Chinese patent for its minimally polarized functional unit (MPFU) technology, enhancing its skin-regenerative compositions. This patent extends the company’s global portfolio to 12 patents, with 10 abroad and 2 in the U.S. Newly, China offers a patent term extension of up to 5 years for new drugs, capping the total term at 14 years. CEO David Seaburg emphasized the company's growth in patent rights, showcasing its commitment to advancing regenerative technologies, especially SkinTE®.
PolarityTE, Inc. (Nasdaq: PTE) reported a business update and Q1 2021 financial results. Total revenues increased by 31% to $4.71 million, with SkinTE revenues rising 44% to $1.73 million. Operating costs dropped by 41% to $10.75 million. Despite positive data from a diabetic foot ulcer trial, the company will cease SkinTE sales due to FDA enforcement discretion ending May 31, 2021. Significant revenue from COVID-19 testing is expected to decline, impacting future earnings. Current cash and equivalents stand at $37.2 million, anticipated to cover operations for at least 12 months.
PolarityTE, Inc. (Nasdaq: PTE) has announced preliminary data from a multi-center trial for treating Diabetic Foot Ulcers with SkinTE® plus standard of care (SOC). The trial met its primary endpoint with a 70% wound closure rate at 12 weeks for those receiving SkinTE compared to 34% for SOC alone (p=0.00032). The secondary endpoint showed a significant Percent Area Reduction (PAR) of 84.4% for SkinTE plus SOC versus 53.5% for SOC (p=0.00024). Full results will be discussed in an upcoming earnings call on May 13, 2021.
PolarityTE, Inc. (Nasdaq: PTE) announced it will report Q1 2021 results on May 13, 2021, around 4:00 p.m. ET. A conference call, including a Q&A session, will follow at 4:30 p.m. ET, accessible via a dial-in or webcast. The earnings call replay will be available for 30 days on the company's website. PolarityTE focuses on developing regenerative tissue products and biomaterials from patients' own tissues, promoting healing through innovative methods. Investors should look out for the financial metrics and operational updates in the upcoming results.
PolarityTE, Inc. reported a significant 79% increase in total revenues to $10.13 million for the fiscal year 2020, compared to $5.65 million in 2019. SkinTE revenues rose by 59% to $3.73 million, bolstered by a strategic focus on repeat users. The company managed to reduce operating costs dramatically by 47%, leading to a net loss of $42.85 million, improved from a loss of $92.49 million in 2019. With a strong cash position of $25.52 million, PolarityTE aims to fund operations well into 2022 as it pursues FDA regulatory approvals for its SkinTE product.
PolarityTE, Inc. (Nasdaq: PTE) will release its financial results for the year ended December 31, 2020, on March 30, 2021, at 7:00 a.m. ET. The Company will follow this with a conference call at 8:00 a.m. ET, accessible via phone or webcast. PolarityTE focuses on developing regenerative tissue products and biomaterials using patients' own tissues to promote healing. The press release includes forward-looking statements cautioning against undue reliance due to potential impacts from COVID-19 and FDA regulatory matters.
PolarityTE (Nasdaq: PTE) recently announced its participation in the H.C. Wainwright Global Life Sciences Virtual Conference scheduled for March 9-10, 2021. A webcast of their presentation will go live on March 9, 2021, at 7:00 a.m. Eastern Time, accessible via the company's website. PolarityTE specializes in regenerative tissue products, aiming to transform patient care through innovative, autologous tissue-based solutions.
PolarityTE, Inc. (Nasdaq: PTE) provides updates on its regenerative tissue products, focusing on the IND submission for SkinTE. The company completed enrollment of 100 subjects in a diabetic foot ulcer trial and aims to file the IND in H2 2021. Financially, PolarityTE ended September 2020 with approximately $23.19 million and raised $25.67 million recently. The company is also strengthening its intellectual property with new patents. Additionally, two lawsuits against the company have been dismissed, reinforcing its legal position.
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