Canady Helios Cold Plasma Scalpel Successfully Used by Chaim Sheba Medical Center Surgeons to Remove Inoperable Retroperitoneal Cancer

On January 29, 2020 A surgical team at The Chaim Sheba Medical Center in Tel HaShomer, Israel, with coordination by US Medical Innovations, LLC (USMI), reported that successfully used the Canady HeliosTM Cold Plasma Scalpel (CHCPS) for a rare advanced reoccurring inoperable retroperitoneal sarcoma (Press release, US Medical Innovations, JAN 29, 2020, View Source [SID1234553666]).

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CHCPS is new cold atmospheric plasma device that specifically eradicates microscopic remnants of cancer cells while sparing normal cells and tissue.

After a one-time pre-market Humanitarian Compassionate-Use Exemption from the Investigational Review Board at Sheba Medical Center, a surgical team successfully used the Canady HeliosTM Cold Plasma Scalpel (CHCPS) for the selective killing of cancerous tissue during the groundbreaking surgery. The surgery was performed on August 20, 2019 on a 33-year-old man with a rare inoperable Retroperitoneal Sarcoma. The patient was first diagnosed at age 20 and the tumor had reoccurred twice prior to this surgery.

Retroperitoneal sarcoma occurs in the retroperitoneum, the area behind the peritoneum. The peritoneum is a thin tissue lining of the abdominal area that covers the abdominal organs. The surgery entailed removing the tumor and its attachment to adjacent tissue in the abdomen. Afterwards, the patient received intra-operative radiation therapy (IORT) at the surgical resected site; cold plasma was subsequently sprayed over the surgical site. The surgery was successful, and the patient returned back to the U.S. in September 2019.

A multidisciplinary group of healthcare professionals and physicians from Sheba Medical Center and research scientists, and engineers from USMI collaborated to achieve this successful outcome. The complex surgery was performed by Aviram Nissum, M.D. Chief of General and Oncological surgery at Sheba Medical Center.

USMI CEO, Chief Science Officer and Surgeon, Jerome Canady, M.D., "USMI and its sister companies are quite excited about the excellent outcome for the patient." We are equally enthusiastic that CHCPS is approved by the FDA for a multi-center phase I clinical trial Investigational Device Exemption (IDE #G190195). Clinical trials will occur at Sheba Medical Center, Tel HaShomer, Israel and Rush University Medical Center, Chicago, Illinois starting February 2020.

McKesson Declares Quarterly Dividend

On January 29, 2020 The Board of Directors of McKesson Corporation (NYSE:MCK) reported that declared a regular dividend of 41 cents per share of common stock (Press release, McKesson, JAN 29, 2020, View Source [SID1234553667]). The dividend will be payable on April 1, 2020, to stockholders of record on March 2, 2020.

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Illumina Reports Financial Results for Fourth Quarter and Fiscal Year 2019

On January 29, 2020 Illumina, Inc. (NASDAQ: ILMN) reported its financial results for the fourth quarter and fiscal year 2019 (Press release, Illumina, JAN 29, 2020, View Source [SID1234553651]).

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Fourth quarter 2019 results:

•Revenue of $953 million, a 10% increase compared to $867 million in the fourth quarter of 2018
•GAAP net income attributable to Illumina stockholders for the quarter of $239 million, or $1.61 per diluted share, compared to $210 million, or $1.41 per diluted share, for the fourth quarter of 2018
•Non-GAAP net income attributable to Illumina stockholders for the quarter of $252 million, or $1.70 per diluted share, compared to $197 million, or $1.32 per diluted share, for the fourth quarter of 2018 (see the "Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" table for a reconciliation of these GAAP and non-GAAP financial measures)
•Cash flow from operations of $443 million compared to $300 million in the fourth quarter of 2018
•Free cash flow (cash flow from operations less capital expenditures) of $386 million for the quarter compared to $235 million in the fourth quarter of 2018

Gross margin in the fourth quarter of 2019 was 69.5% compared to 68.1% in the prior year period. Excluding amortization of acquired intangible assets, non-GAAP gross margin was 70.2% for the fourth quarter of 2019 compared to 69.1% in the prior year period.

Research and development (R&D) expenses for the fourth quarter of 2019 were $161 million compared to $176 million in the prior year period. Excluding restructuring charges, non-GAAP R&D expenses as a percentage of revenue were 16.8% compared to 20.3% in the prior year period.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2019 were $233 million compared to $217 million in the prior year period. Excluding amortization of acquired intangible assets, acquisition-related expenses, and restructuring charges, non-GAAP SG&A expenses as a percentage of revenue were 22.2% compared to 24.5% in the prior year period.

Depreciation and amortization expenses were $46 million and capital expenditures for free cash flow purposes were $57 million during the fourth quarter of 2019. At the close of the quarter, the company held $3.4 billion in cash, cash equivalents and short-term investments, compared to $3.5 billion as of December 30, 2018.

Fiscal year 2019 results:

•Revenue of $3,543 million, a 6% increase compared to $3,333 million in fiscal 2018
•GAAP net income attributable to Illumina stockholders of $1,002 million, or $6.74 per diluted share, compared to $826 million, or $5.56 per diluted share, in fiscal 2018
•Non-GAAP net income attributable to Illumina stockholders of $976 million, or $6.57 per diluted share, compared to $850 million, or $5.72 per diluted share, in fiscal 2018. Non-GAAP net income excludes unrealized net gains of $66 million from mark-to-market adjustments on our strategic investments, primarily from our marketable equity securities (see the "Itemized Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" table for a reconciliation of these GAAP and non-GAAP financial measures)
•Cash flow from operations of $1,051 million compared to $1,142 million in fiscal 2018

•Free cash flow (cash flow from operations less capital expenditures) of $842 million, compared to $846 million in fiscal 2018

Gross margin for fiscal 2019 was 69.6% compared to 69.0% in the prior year. Excluding amortization of acquired intangible assets, non-GAAP gross margin was 70.6% for fiscal 2019 compared to 70.1% in the prior year period.

R&D expenses for fiscal 2019 were $647 million compared to $623 million in the prior year. Excluding restructuring charges, non-GAAP R&D expenses as a percentage of revenue were 18.2% compared to 18.7% in the prior year period.

SG&A expenses for fiscal 2019 were $835 million compared to $794 million in the prior year period. Excluding amortization of acquired intangible assets, acquisition-related expenses, and restructuring charges, non-GAAP SG&A expenses as a percentage of revenue were 22.0% compared to 23.6% in the prior year period.

"Illumina shipped a record 2,400 sequencing systems in 2019, including a record number of our high-throughput NovaSeq systems and mid-throughput NextSeq systems, reflecting strong demand for research and clinical sequencing," said Francis deSouza, President and CEO. "With the launch of our most innovative system to date in the NextSeq 2000, and a growing pipeline of clinical IVD and software solutions, Illumina continues to improve the accessibility of sequencing. Almost 17 years after the first human genome was sequenced, we believe that this is the decade that genomics becomes available to cancer and genetic disease patients on a mass scale and integrates into standard of care."

Updates since our last earnings release:

•Announced the NextSeq 1000 and NextSeq 2000 Sequencing Systems offering breakthrough system design, chemistry innovations and on-instrument integrated informatics for rapid secondary analysis
•Shared plans for additional product launches including TruSight Software Suite to enable sample-to-report for genetic disease and NovaSeq Dx to fulfill the growing interest in a Dx platform for deeper sequencing at higher throughput, and TruSight NIPT
•Partnered with Roche to broaden the adoption of distributable next-generation sequencing-based (NGS) testing in oncology
•Partnered with Genomics England to provide sequencing services to the United Kingdom’s National Health Service to sequence 300,000 to 500,000 whole genomes by 2025
•Mutually terminated the merger agreement with Pacific Biosciences
•Filed patent infringement suits against BGI in Sweden and the United Kingdom
•Repurchased $63 million of outstanding common stock in the fourth quarter of 2019 under the previously announced share repurchase program, which had a remaining balance of approximately $226 million as of December 29, 2019

Financial outlook and guidance

The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our core operational performance. Please see our Reconciliation of Non-GAAP Financial Guidance included in this release for a reconciliation of the GAAP and non-GAAP financial measures.

For fiscal 2020, the company expects year over year revenue growth in the range of 9% to 11%, and expects GAAP earnings per diluted share of $6.45 to $6.65 and non-GAAP earnings per diluted share of $6.80 to $7.00. GAAP guidance does not include any potential impact resulting from the termination of our merger agreement with Pacific Biosciences on January 2, 2020.

Quarterly conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Wednesday, January 29, 2020. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "Company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (866) 211-4597 or 1 (647) 689-6853 outside North America, both with conference ID 2966099.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

Pulse Biosciences to Present Data on Nano-Pulse Stimulation Technology for Nodular Basal Cell Carcinoma at IMCAS World Congress 2020

On January 29, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company"), a novel bioelectric medicine company, reported the presentation of its scientific study evaluating the clinical and histologic response of Nano-Pulse Stimulation (NPS) technology in treating challenging cases of nodular Basal Cell Carcinoma (nBCC) (Press release, Pulse Biosciences, JAN 29, 2020, View Source [SID1234553668]). These results are to be presented at the 22nd annual IMCAS (International Master Course on Aging Skin) World Congress, the gathering of international experts in dermatology, plastic surgery and aging science, taking place at Palais des Congrès, Paris, France, from January 30th to February 1st 2020.

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Dermatologist Girish Munavalli, MD, MHS, FACMS, a prominent skin cancer surgeon in Charlotte, NC, will present results that demonstrate the unique ability of NPS technology to eliminate tumor cells in nodular BCCs while sparing surrounding healthy tissue. Results will be supported by clinical photos that display a more favorable cosmetic outcome possible in a short amount of time with reduced potential for scar formation as compared to current surgical excision.

Basal cell carcinoma is the most common form of skin cancer worldwide. The nodular BCC subtype reported in this study comprises 60% of all basal cell carcinomas. For these deep nodular lesions, the current standard of care is surgical excision, which can lead to large, permanent scars.

"Early findings show promising potential for NPS technology as a new treatment option for nodular BCC. NPS technology has demonstrated equivalent therapeutic benefit and the added benefit of superior cosmetic outcomes compared to more destructive skin cancer treatment modalities, such as excision and curettage," said Dr. Munavalli of Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC.

"We are enthusiastic about the impressive results Nano-Pulse Stimulation technology is producing in Basal Cell Carcinomas and are focused on rapidly advancing its development program across multiple clinical applications," said Darrin Uecker, President and CEO of Pulse Biosciences. "Our presence at IMCAS represents the initial step in our commitment to international commercialization, which aims to extend our long-term growth platform and leverage the value proposition of our technology’s ability to clear benign and malignant lesions. "

Scheduled scientific presentation at IMCAS World Congress 2020

Podium Presentation: "Histologic and Clinical Comparison of Scar Cosmesis Using Nano-Pulse Stimulation vs Traditional Surgical Treatments of Basal Cell Carcinoma," by Dr. Girish S. MUNAVALLI, Assistant Professor at the Wake Forest University School of Medicine – Department of Dermatology and Medical Director and Founder of Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte NC.

Details: 30 January 2020, at 12:06pm in Room 143, Level 1
Skin Cancer and Photorejuvenation: The Impossible Equation: Session S011, S012
Chaired by: Dr. Mathew Avram and Pr. Merete Haedersdal.

Innovation Pharmaceuticals Further Engages Locust Walk to Lead Out-Licensing Negotiations for Rights to Phase 3-Ready Oral Mucositis Drug Candidate

On January 29, 2020 Innovation Pharmaceuticals Inc. (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, has further engaged Locust Walk, a leading global life sciences transaction firm serving as its strategic advisor, to lead the Company’s out-licensing negotiations for rights to oral rinse Brilacidin for the treatment of Oral Mucositis (OM) (Press release, Innovation Pharmaceuticals, JAN 29, 2020, View Source [SID1234553652]).

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The Company had previously engaged Locust Walk to assess the value of its clinical assets, which included recently an in-depth assessment of the commercial opportunity of oral rinse Brilacidin-OM—a Phase 3-ready, FDA Fast Track-designated clinical asset in late-stage development targeting a substantial untapped market in supportive cancer care.

This renewed engagement is a continuation of Innovation Pharmaceutical’s business relationship with Locust Walk toward realizing the market potential of the Company’s pipeline.