On January 30, 2020 Portage Biotech Inc. (PBT.U, OTC Markets: PTGEF) ("Portage" or the "Company") is reported it has increased its subscription to iOx’s convertible loan to $2.9M USD, (previous subscriptions totalled $1.9M on December 8th, 2018) (Press release, Portage Biotech, JAN 30, 2020, View Source [SID1234553722]).

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iOx Therapeutics, Ltd. ("iOx") is a United Kingdom-based immuno-oncology company. Portage will invest $950,000 by subscribing to an unsecured, convertible loan instrument. iOx will use the proceeds to enable the start of human studies this year. The notes carry a 7% interest rate and will price at a discount to the next round of financing into iOx. The terms of the notes differ from those announced previously as these carry two year warrants to purchase additional shares at the same price as the next financing. All three convertible notes currently held by Portage have been extended.

Greg Bailey, Chairman of Portage, remarked, "We are looking forward to iOx achieving a major milestone and begin to collect safety data in cancer patients. This bridge financing will support the iOx team to advance this asset as well as to continue to support the PRECIOUS consortium in Europe who has received Horizon 2020 funding to advance its second drug candidate into the clinic."

Related Party Transaction

The transaction is a related party transaction within the meaning of Multilateral Instrument 61-101 Protection of Minority Shareholders in Special Transactions ("MI 61-101") as Portage’s CEO, Dr. Ian B. Walters serves as iOx’s CEO and Dr. Declan Doogan, a director of Portage, is iOx’s chairman. The transaction, however, is exempt from both formal valuation and minority shareholder approval requirements under MI 61-101. The Company has relied on exemptions from the formal valuation and minority shareholder approval requirements of MI 61‑101 contained in sections 5.5(a), 5.5(b) and 5.7(1)(a) of MI 61‑101 in respect of related party participation in this transaction as neither the fair market value (as determined under MI 61-101) of the subject matter of, nor the fair market value of the consideration for, the transaction, insofar as it involved the related parties, exceeded 25% of the Company’s market capitalization (as determined under MI 61-101).

Corporate Update

The Company is also providing an update on the status of its application (the "Revocation Application") to the Ontario Securities Commission (the "OSC") to revoke an outstanding cease trade order issued on August 2, 2019 (the "CTO").

The OSC has commenced their review of the Revocation Application (filed on January 13, 2020) and issued an initial set of comments. The Company is currently preparing a response which is expected to be submitted shortly. As the relief being sought is discretionary, no estimate can be provided as to when a revocation order may be issued by the OSC. The Company, though, would like to take this opportunity to thank its shareholders for their continued patience. It is the Company’s every intention to complete the OSC’s review process in a timely manner.

On January 30, 2020 CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, reported that 2019 fourth quarter and year-end financial results will be released on Thursday, February 13, 2020 after the market closes (Press release, CryoLife, JAN 30, 2020, View Source [SID1234553721]). On that day, the Company will hold a teleconference call and live webcast at 4:30 p.m. ET to discuss the results, followed by a question and answer session hosted by Pat Mackin, Chairman, President and Chief Executive Officer of CryoLife, Inc.

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To listen to the live teleconference, please dial 201-689-8261 a few minutes prior to 4:30 p.m. ET. A replay of the teleconference will be available February 13 through February 20 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The conference number for the replay is 13698400.

The live webcast and replay can be accessed in the Investor Relations section of the CryoLife website at www.cryolife.com and selecting Webcasts & Presentations. In addition, a copy of the earnings press release, which will contain financial and statistical information for the completed quarter and full year, can be accessed in the Investor Relations section of the CryoLife website.

On January 30, 2020 AnPac Bio-Medical Science Co., Ltd. ("AnPac Bio" or the "Company") (NASDAQ: ANPC), a biotechnology company with operations in China and the United States focused on early cancer screening and detection, reported that it has priced its initial public offering of 1,333,360 American depositary shares ("ADSs") at US$12.00 per ADS for a total offering size of approximately US$16.0 million, assuming the underwriters do not exercise their over-allotment option to purchase additional ADSs (Press release, Anpac Bio, JAN 30, 2020, View Source [SID1234553720]). Each ADS represents one Class A ordinary share of the Company. The ADSs are expected to begin trading on the Nasdaq Global Market on January 30, 2020 under the ticker symbol "ANPC."

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The Company has granted the underwriters an option, exercisable within 30 days from the date of the final prospectus, to purchase up to an aggregate of 200,004 additional ADSs at the initial public offering price, less underwriting discounts and commissions, to cover over-allotments.

WestPark Capital, Inc. and Univest Securities, LLC are acting as joint bookrunners of this offering and as the representatives of the underwriters.

AnPac Bio’s registration statement relating to the offering has been filed with, and declared effective by, the United States Securities and Exchange Commission. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of, these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On January 30, 2020 Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, reported financial results for the quarter ended December 31, 2019 (Press release, Edwards Lifesciences, JAN 30, 2020, View Source [SID1234553719]).

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Fourth Quarter Results and Outlook

Q4 sales grew 20% to $1.2 billion; underlying1 sales grew 19%
Q4 TAVR sales grew 29%; underlying sales grew 30%
Q4 EPS was $1.32; adjusted1 EPS grew 25% to $1.46
Full year 2019 sales and earnings significantly exceeded original guidance
2020 guidance ranges increased: sales $4.6 billion to $5.0 billion; EPS $6.15 to $6.40
SAPIEN 3 transcatheter heart valve received low risk indication expansion in Europe
EVOQUE tricuspid early feasibility study receives FDA approval
"We are pleased to report robust fourth quarter performance that delivered 19 percent sales growth on an underlying basis, driven by our portfolio of innovative technologies. For the full year 2019, we reported 15 percent revenue growth on an underlying basis, with double-digit growth in each region," said Michael A. Mussallem, chairman and CEO. "Most importantly, I’m proud to report we’re poised to help even more patients benefit from Edwards’ life-saving technologies. We invested aggressively in transformative therapies in 2019 and this will continue in 2020 as our commitment has never been greater."

2019 Full Year Results

Sales for the year ended December 31, 2019 were $4.3 billion, up 17 percent over the prior year, or 15 percent on an underlying basis. Diluted earnings per share for 2019 were $4.93, while adjusted earnings per share grew 19 percent, to $5.57.

Transcatheter Aortic Valve Replacement (TAVR)

The company reported fourth quarter global TAVR sales of $763 million, a year-over-year increase of approximately 30 percent on both a reported and underlying basis with impressive strength in the U.S. Global average selling prices remained stable.

In the fourth quarter, the company estimates U.S. TAVR procedures grew approximately 40 percent on a year-over-year basis and Edwards’ growth was comparable. Outside the U.S., the company estimates that total TAVR procedures grew in the high-teens on a year-over-year basis and Edwards’ growth was comparable. As previously reported, Edwards became the first company to receive CE Mark for TAVR in Europe for the treatment of patients diagnosed with severe aortic stenosis who are at low risk for open-heart surgery.

Transcatheter Mitral and Tricuspid Therapies (TMTT)

TMTT is on track to achieve the milestones discussed at the company’s recent Investor Conference, including executing four pivotal studies. In addition, the company announced that the EVOQUE tricuspid replacement valve system has recently received U.S. Food and Drug Administration (FDA) approval for an Early Feasibility Study and a "breakthrough device" designation, a program intended to help patients receive more timely access to designated medical technologies.

Full year 2019 TMTT sales of $28 million came in below the original guidance of approximately $40 million as the company continued to execute a disciplined introduction and premium pricing strategy of the PASCAL system, which moderated European site activation. Fourth quarter sales of $7 million were negatively impacted by the voluntary PASCAL system field corrective action completed in the quarter. PASCAL clinical outcomes continue to be favorable and physician feedback remains positive. As the PASCAL system roll-out expands, the company will remain focused on procedural success and differentiated patient outcomes.

Surgical Structural Heart and Critical Care

Surgical Structural Heart sales for the quarter were $205 million, down one percent compared to the fourth quarter of 2018, and down three percent on an underlying basis. The sales decline was the result of lower surgical aortic valve procedures in the U.S. as TAVR adoption increased, partially offset by continued strong adoption of the company’s premium high-value technologies.

Critical Care sales were $199 million for the quarter, representing an increase of 12 percent versus the fourth quarter of 2018 or eight percent on an underlying basis. This performance was driven by strong demand for the HemoSphere advance monitoring platform and continued adoption of Smart Recovery. Growth in the quarter was led by sales in the U.S.

Additional Financial Results

For the quarter, the company’s adjusted gross profit margin was 75.8 percent, compared to 76.1 percent in the same period last year. This reduction was driven by spending in support of the new European medical device regulations and one-time costs associated with migrating Cardioband production from Israel to Ireland, partially offset by the benefit of a more profitable product mix.

Selling, general and administrative expenses increased 21 percent to $347 million for the quarter, driven by increased field clinical personnel to support TAVR cases in the U.S. and TMTT cases in Europe, as well as accelerated actions related to disease awareness and therapy adoption.

Research and development for the fourth quarter increased 19 percent to $194 million, or 16.5 percent of sales. This increase was primarily the result of continued investments in the company’s transcatheter structural heart programs, including spending on clinical trials.

Free cash flow for the fourth quarter was $328 million, defined as cash flow from operating activities of $399 million, less capital spending of $71 million.

Cash, cash equivalents and short-term investments totaled $1.5 billion at December 31, 2019. Total debt was $594 million.

Outlook

Overall, 2020 sales guidance for Edwards is now expected to be $4.6 to $5.0 billion versus the company’s previous range of $4.5 to $5.0 billion. Additionally, the company now expects full year 2020 adjusted earnings per share of $6.15 to $6.40 versus previous guidance of $6.05 to $6.30.

For the first quarter of 2020, the company projects total sales to be between $1.15 and $1.2 billion, and adjusted EPS of $1.49 to $1.59.

"We were very proud of the significant progress we made in advancing transformational therapies in 2019, as well as our strong financial performance. We are enthusiastic about the future of transcatheter-based technologies, and the promise of treating the many structural heart patients still in need, which positions us very well for 2020 and beyond. We firmly believe our patient-focused innovation strategy can transform care and bring value to patients, healthcare systems, and shareholders," said Mussallem.

On January 30, 2020 MedX Health Corp. ("MedX" or the "Company") (TSX-V:MDX) is reported that it has received Conditional Approval from the TSX Venture Exchange for a non-brokered Private Placement to accredited investors of up to 25,000,000 units at $0.12 per unit ("Unit"), to raise up to $3,000,000 (Press release, MedX Health, JAN 30, 2020, View Source [SID1234553718]). Each Unit will be comprised of One (1) fully paid common share and One (1) Share Purchase Warrant, exercisable to purchase One (1) further Common Share at the price of $0.20, exercisable for a period of two years from the date of issue. Closing of the Placement, which will take place in tranches, will be subject to receipt of subscriptions and a number of other conditions, including without limitation the receipt of all relevant regulatory and Stock Exchange approvals or acceptances. Qualified Agents may receive commissions in respect of subscriptions introduced by them by way of cash equal to 8% of funds so introduced, and issuance of agent’s warrants ("Agent’s Warrant(s)") equal in number to 8% of the number of units so subscribed for. Each Agent’s Warrant, which is non-transferable, will be exercisable to acquire one Unit at $0.12 per Unit, at any time during the period of two years following the Closing.

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The Company further announces that on January 30, 2020, it closed a first tranche of the Private Placement by issuing a total of 1,485,000 Units, to raise $178,200 from accredited investors. The securities issued on January 30, 2020, will be restricted from trading for four months. In connection with this first Closing, a cash commission of $10,080 was paid and 84,000 Agent’s Warrants were issued. Following this first Closing, the Private Placement offering remains open for further subscriptions, subject to all relevant regulatory and other consents and approvals, including acceptance by the TSX Venture Exchange.