CWRU and UH researchers secure $4 Million in NCI funding to investigate relationships between HIV and lung cancer in East Africa

On October 28, 2020 Researchers with Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center (UHCMC) reported that they have secured $4 million in funding from the National Institutes of Health (NIH)/National Cancer Institute (NCI) to establish an HIV-associated Malignancy Research Center (HAMRC) focused on lung cancer in East Africa (Press release, Case Western Reserve University, OCT 28, 2020, View Source [SID1234569203]).

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The team will collaborate with Ugandan and Tanzanian researchers at the Joint Clinical Research Centre in Kampala, Makerere University Lung Institute, Uganda Cancer Institute, Mulago National Hospital, National Institute for Medical Research (NIMR), Muhumbili National Hospital and the Ocean Road Cancer Institute. The HAMRC will investigate novel approaches to characterize lung cancer epidemiology, somatic mutation burden, HIV and accelerated aging, and radiological features of lung cancer and the relationship to HIV-1 infection.

The focus of this new research center includes establishing national lung cancer diagnostic referral networks in Uganda and Tanzania, teleradiology telepathology, technology transference, and training of early career investigators and personnel.

This cross-continental effort is led by:

Robert A. Salata, Case Western Reserve/UHCMC;
Stan Gerson, Case Western Reserve;
Bruce Kirenga, Makerere University Lung Institute; and
Sayoki Mfinanga, National Institute for Medical Research, Muhimbili Centre, Tanzania.
The CCCC, which has a history of coordinating large, multi-institution projects, will provide administrative support, while the Joint Clinical Research Centre is the central site of research activity.

This five-year effort will take a comprehensive approach to better define the genetic and molecular determinants of lung cancer and how they impact—or are impacted by—HIV, a condition prevalent in these countries. This research aims to develop diagnostic computational imaging algorithms to discern lung cancer from other types of respiratory infections—especially tuberculosis, which is frequent in these African countries among patients with and without HIV.

The HAMRC will harness Case Western Reserve’s Center for Computational Imaging and Personalized Diagnostics (CCIPD) expertise in artificial intelligence (AI) to study lung cancer and the relationship to HIV-1 infection using radiological scans.

"We know from prior research that there are correlations between HIV and higher rates of lung cancer, and we hypothesize that HIV with its immunosuppression contributes to premature immunological aging, a known risk factor for lung cancer," said Salata, chair of Case Western Reserve’s Department of Medicine and program director of the UH Roe Green Center for Travel Medicine & Global Health. "We will use advanced imaging capabilities coupled with novel AI and computational approaches to support accurate and timely diagnosis."

Case Western Reserve and Makerere University have forged a research collaboration for 32 years, resulting in breakthroughs in characterizing the epidemiology and molecular-level mechanisms of conditions including tuberculosis, HIV and various forms of cancer.

"Collaborations like this one are part of the global priorities of the National Cancer Institute to advance the global medical community’s understanding of the interrelations between complex diseases and cancer, and how to treat them appropriately," said Gerson, CCCC director and interim dean of the School of Medicine. "While our focus for this series of projects is on the inter-relatedness of HIV, including increased risks for cancer, we anticipate that findings will inform diagnostic capabilities and personalized treatment for many types of cancer that present uniquely or that are accelerated in immunocompromised patients."

Kirenga, director and pulmonologist at the Makerere University Lung Institute, and Mfinanga, NIMR director, have worked together on various large-scale, multi-country projects since 2009, notably on tuberculosis, which has informed the global community’s understanding of this and other infectious disease.

"This collaboration with CWRU and the Case Comprehensive Cancer Center builds on decades of relationships that have advanced understanding worldwide about diseases that do not recognize maps and borders," Kirenga said. "The global community of cancer and infectious disease translational researchers recognize the importance of deepening our understanding of how complex conditions inform one another. This collaboration builds on a history of work that has resulted in better diagnostics and treatment for many conditions that touch thousands of lives worldwide."

Research team leadership includes:

Anant Madabhushi, director of CCIPD and the Donnell Institute Professor of Biomedical Engineering, Case Western Reserve;
Afshin Dowlati, professor of medicine at Case Western Reserve and director of the Thoracic Oncology Program at University Hospitals Seidman Cancer Center;
Joseph Willis, professor of medicine at Case Western Reserve and vice chairman of Pathology for Translational Research at University Hospitals Cleveland Medical Center; and
Simon Kasasa, senior lecturer of epidemiology and biostatistics at Makerere University.

ChromaDex to Report Third Quarter 2020 Financial Results on Wednesday, November 4, 2020

On October 28, 2020 ChromaDex Corp. (NASDAQ:CDXC) reported that it will hold a conference call on Wed., November 4, 2020 at 4:30 p.m. ET to discuss its financial results for the third quarter ended September 30, 2020 (Press release, ChromaDex, OCT 28, 2020, View Source [SID1234569202]). The financial results will be reported in a press release after the close of regular stock market trading hours on the same day as the conference call.

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Investor Conference Call:

ChromaDex management will host an investor conference call to discuss the third quarter results and provide a general business update on Wed., November 4, at 4:30 p.m. ET.

Participants should call in at least 10 minutes prior to the call. The dial-in information is as follows:

Date: Wed., November 4, 2020
Time: 4:30 p.m. ET (1:30 p.m. Pacific time)
Toll-free dial-in number: 1-833-979-2703
International dial-in number: 236-714-2223
Conference ID: 4699759
Webcast link: ChromaDex Third Quarter 2020 Earnings Conference Call

The conference call will be broadcast live and available for replay here and via the investor relations section of the Company’s website at www.chromadex.com.

A replay of the conference call will be available after 7:30 p.m. ET.

Boston Scientific Announces Results For Third Quarter 2020

On October 28, 2020 Boston Scientific Corporation (NYSE: BSX) reported that sales of $2.659 billion during the third quarter of 2020 (Press release, Boston Scientific, OCT 28, 2020, View Source [SID1234569201]). This represents a decline of (1.8) percent on a reported basis, (2.5) percent on an operational1 basis and (5.7) percent on an organic2 basis, all compared to the prior year period. The company reported a GAAP net loss available to common stockholders of $(169) million or $(0.12) per share (EPS), compared to GAAP net income of $126 million or $0.09 per share a year ago, and achieved adjusted EPS of $0.37 for the period, compared to $0.39 a year ago.

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"We have a robust cadence of new product launches across our portfolio, and in the third quarter, we delivered strong sequential improvement in our financial performance," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "I am grateful to our global team for their winning spirit and remain confident that our pipeline of products and services positions us well to continue delivering growth at the high end of our peer group."

Third quarter financial results and recent developments:

Included within organic sales results is a negative 230 basis point impact associated with the conversion of U.S. WATCHMAN customers to a consignment inventory model and transition to the next-generation WATCHMAN FLX.

Reported a GAAP net loss available to common stockholders of $(0.12) per share and achieved adjusted EPS of $0.37. The company had not provided third quarter sales and EPS guidance due to ongoing uncertainty associated with the scope and duration of the COVID-19 pandemic.
Included in adjusted EPS is a $(0.04) impact from WATCHMAN discussed above, offset by a $0.06 tax benefit3.

Third quarter sales declined in each of our reportable segments5, compared to the prior year period:
MedSurg: (2.3) percent reported, (3.0) percent operational and (1.9) percent organic
Rhythm and Neuro: (3.0) percent reported, (3.9) percent operational and organic
Cardiovascular: (5.3) percent reported, (5.9) percent operational and (10.4) percent organic

Generated third quarter regional6 sales growth/(declines), compared to the prior year period:
U.S.: (4.2) percent reported and operational
EMEA (Europe, Middle East and Africa): 0.8 percent reported and (2.9) percent operational
APAC (Asia-Pacific): (2.6) percent reported and (4.1) percent operational
Emerging Markets4: (10.3) percent reported and (7.1) percent operational

Received FDA approval for the AVVIGO Guidance System, a tablet platform designed to provide ease of use and accuracy when utilizing fractional flow reserve wires during percutaneous coronary intervention procedures.

Received FDA approval for the high bleeding risk indication for the SYNERGY and SYNERGY XD Bioabsorbable Polymer Drug-Eluting Stent Systems (excluding the recently launched 48 mm stent size).

Obtained CE Mark and initiated a limited market release in Europe of the WaveWriter Alpha portfolio of spinal cord stimulator (SCS) systems, consisting of four full-body MRI conditional, Bluetooth-enabled devices to provide personalized treatment for chronic intractable pain.7

Obtained CE Mark and initiated a limited market release in Europe of the fourth generation Vercise Genus Deep Brain Stimulation (DBS) System to treat the symptoms of Parkinson’s disease, essential tremor and dystonia by delivering precisely targeted electrical stimulation, with full-body MRI conditional and Bluetooth capabilities to better meet individuals’ specific needs.8

Commenced the full global launch of the SpyGlass Discover Digital Catheter, the first single-use scope to enable physicians to take a single-stage approach to diagnostic and therapeutic procedures in the pancreaticobiliary system, including treating patients with bile duct stones.

Initiated the U.S. launch of the SpaceOAR Vue Hydrogel, a next-generation hydrogel spacer that is designed to reduce the side effects of prostate radiation therapy, while providing clinicians with the added ability to view the spacer using computerized tomography (CT) scans instead of magnetic resonance imaging (MRI).

Initiated the European launch of the ACURATE neo2 Aortic Valve System, a new transcatheter aortic valve implantation platform designed to minimize paravalvular leaking and facilitate highly accurate positioning, for patients with aortic stenosis.

Received a New Technology Add-on Payment (NTAP) designation from the U.S. Centers for Medicare and Medicaid Services for the Eluvia Drug-Eluting Vascular Stent System, developed for the treatment of PAD, providing eligible hospitals with incremental reimbursement for the Eluvia stent system. The NTAP designation is awarded to new medical devices determined to substantially improve the diagnosis or treatment of Medicare beneficiaries and went into effect on October 1, 2020.

Announced an expanded investment and exclusive acquisition option agreement with Farapulse, Inc., a privately-held company developing a pulsed field ablation system for the treatment of atrial fibrillation (AFib) and other cardiac arrhythmias via the creation of a therapeutic electric field.

1. Operational revenue growth excludes the impact of foreign currency fluctuations.

2. Organic revenue growth excludes the impact of foreign currency fluctuations and net sales associated with our Q3 2019 acquisition of BTG plc (BTG) for the period prior to mid-August, for which there were no prior period net sales. Organic revenue growth also excludes the impact of the divestiture of our global embolic microspheres portfolio, a transaction entered into in connection with obtaining the antitrust clearances required to complete the BTG transaction, also for the period prior to mid-August, as well as prior period net sales associated with our intrauterine health franchise, which we divested in Q2 2020.

3. We recorded a $0.06 non-cash tax benefit due to the resolution of the IRS examination of our 2014 through 2016 tax years.

4. We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities.

5. We have three historical reportable segments comprised of Medical Surgical (MedSurg), Rhythm and Neuro, and Cardiovascular, which represent an aggregation of our operating segments that generate revenues from the sale of medical devices (Medical Devices). As part of our acquisition of BTG on August 19, 2019, we acquired an Interventional Medicine business, which is now included in our Peripheral Interventions operating segment’s revenues from the date of acquisition. We have revised amounts for the third quarter of 2019 to conform to the current year presentation..

6. As part of our acquisition of BTG on August 19, 2019, we acquired a specialty pharmaceuticals business (Specialty Pharmaceuticals). Subsequent to acquisition, Specialty Pharmaceuticals is now a stand-alone operating segment presented alongside our Medical Device reportable segments. We have revised amounts for the third quarter of 2019 to conform to the current year presentation. Specialty Pharmaceuticals net sales are substantially U.S. based. Our chief operating decision maker (CODM) reviews financial information of our globally managed Specialty Pharmaceuticals operating segment at the worldwide level without further disaggregation into regional results. As such, Specialty Pharmaceuticals net sales are presented globally, and our Medical Devices reportable segments regional net sales results do not include Specialty Pharmaceuticals.

7. The WaveWriter Alpha and WaveWriter Alpha Prime Spinal Cord Stimulator Systems provide safe access to full-body 1.5T MRI scans when used with specific components and exposed to the MRI environment under the defined conditions in the ImageReady MRI Full Body Guidelines for WaveWriter Alpha and WaveWriter Alpha Prime Spinal Cord Stimulator Systems.

8. 1.5 Tesla MRI conditional when all conditions of use are met.

*In the third quarter of 2019, we presented Interventional Medicine and Specialty Pharmaceuticals together as "BTG Acquisition" and outside of our operating and reportable segments net sales. Following the integration of BTG, we now include Interventional Medicine business within our Peripheral Interventions operating segment, within the Cardiovascular reportable segment. We present Specialty Pharmaceuticals business as a standalone operating segment alongside our reportable segments. We have revised amounts for the third quarter of 2019 to conform to the current year presentation.

*In the third quarter of 2019, we presented Interventional Medicine and Specialty Pharmaceuticals together as "BTG Acquisition" and outside of our operating and reportable segments net sales. Following the integration of BTG, we now include Interventional Medicine business within our Peripheral Interventions operating segment, within the Cardiovascular reportable segment. We present Specialty Pharmaceuticals business as a standalone operating segment alongside our reportable segments. We have revised amounts for the third quarter of 2019 to conform to the current year presentation.

Amounts may not add due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of recent aforementioned acquisitions / divestitures are not prepared in accordance with U.S. GAAP.

Conference Call Information

Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. EDT. The company will webcast the call to interested parties through its website: www.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.

Integra LifeSciences Reports Third Quarter 2020 Financial Results

On October 28, 2020 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the third quarter ending September 30, 2020 (Press release, Integra LifeSciences, OCT 28, 2020, View Source [SID1234569198]).
Third Quarter 2020 Financial Summary

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Reported revenues were $370.2 million, representing a decrease of 2.3% on a reported basis and a decrease of 1.5% on an organic basis compared to the prior year. These results were at the high end of the preliminary range provided on October 6, 2020;

Third quarter reported revenues increased 43.1% compared to the second quarter 2020;

GAAP earnings per diluted share were $0.38, compared to a GAAP loss of ($0.32) in the third quarter of 2019. Adjusted earnings per diluted share were $0.80, compared to $0.68 in the prior year;

The Company’s full-year 2020 guidance remains withdrawn due to the uncertainty related to COVID-19 and ongoing variability in the recovery in surgical procedure volumes.
"Better than expected performance in the third quarter was driven by stronger recovery trends and solid execution across the organization," said Peter Arduini, Integra’s president and chief executive officer. "I am proud of the ongoing commitment from our Integra colleagues, who are working tirelessly to deliver life-saving products to customers and patients. Barring significant worsening of the pandemic, we believe these efforts will result in a further sequential revenue improvement in the fourth quarter."

The Company reported GAAP gross margin of 63.6%, compared to 62.4% in the third quarter of 2019. Adjusted gross margin was 68.6% compared to 67.0% in the prior year.
Adjusted EBITDA for the third quarter of 2020 was $103.2 million, or 27.9% of revenue, compared to $91.6 million, or 24.2% of revenue in the prior year.
The Company reported GAAP net income of $32.3 million, or $0.38 per diluted share, in the third quarter of 2020, compared to a GAAP net loss of ($27.6) million, or ($0.32) per diluted share in the prior year. The GAAP loss in

the third quarter of 2019 included a charge of $59.9 million related to an in-process R&D charge associated with the Rebound Therapeutics acquisition.
Adjusted net income for the third quarter of 2020 was $67.7 million, or $0.80 per diluted share, compared to $58.7 million, or $0.68 per diluted share in the prior year.
Integra’s financial position and liquidity remain strong. The Company ended the quarter with $396 million in cash and cash equivalents, $1.2 billion in undrawn revolver capacity, and a consolidated total leverage ratio of 3.2x.
On September 29, 2020, the Company announced it had entered into a definitive agreement to sell its Extremity Orthopedics business. The transaction is expected to close at or around the end of 2020, subject to the satisfaction of customary conditions including regulatory approvals and consultation with employee representative bodies.
2020 Full-Year Outlook
Due to the ongoing uncertainty around the scope and duration of the pandemic and the timing of recovery across the globe, the Company’s guidance for the full-year 2020 remains withdrawn. Barring significant worsening of the pandemic, the Company expects further sequential revenue improvement in the fourth quarter. The Company does not expect all markets or all product lines to improve at the same rate. The level and location of COVID-19 case emergence or recurrence and its associated impact on surgical procedure volumes and economic recovery, will shape the Company’s financial progress.
Supplemental financial and operational information is included in a presentation that can be found in the "Investor" section of the Company’s website at investor.integralife.com under "Events & Presentations".
In the future, the Company may record, or expects to record, gains or losses, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online
Integra has scheduled a conference call for 8:30 a.m. ET today, Wednesday, October 28, 2020, to discuss financial results for the third quarter. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the prepared remarks.
Integra’s management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com.
Access to the live call is available by dialing (800) 353-6461 and using the passcode 9501226. The call can also be accessed via a webcast link provided on investor.integralife.com. A replay of the call will be available until November 2, 2020 by dialing (888) 203-1112 and using the passcode 9501226. The webcast will also be archived on the website.

West Announces Increase to Fourth-Quarter 2020 Dividend

On October 28, 2020 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that the Company’s Board of Directors has approved a fourth-quarter 2020 dividend of $0.17 per share, a 6.25% increase over the $0.16 per share declared for each of the four preceding quarters (Press release, West Pharmaceutical Services, OCT 28, 2020, View Source [SID1234569197]). This is the twenty-eighth consecutive annual increase in the Company’s dividend. The dividend will be paid on November 18, 2020, to shareholders of record as of November 11, 2020.

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