“As a result, we gained comfort with our near-term assumptions and increased our instrument placements and utilization rates in 2015, resulting in raising our revenue expectation to $70-million from $65-million,” writes analyst Jeff Frelick.

He said his new price target assumes a price-to-sales multiple of 6.5 times the new 2015 sales estimate, discounted at 15% to 2014.

Based on the interviews, he said the speed and ease-of-use of the TearLab osmolarity system for dry eye disease (DED)  is high on the list of importance, along with the CLIA-waiver and reimbursement. “Providing a four-second test ensures there is no disruption to workflow,” he added.

Mr. Frelick said veteran ophthalmologists commented that they see more patients with DED today than 10-to-15 years ago due to an aging population, environmental conditions, and better diagnostic tests.

The trial is a multicenter, open-label, dose escalation study that is taking place at cancer centers in both the U.S. and Canada. The trial is designed to assess safety and tolerability in patients with advanced cancer tumors, with a weighting on ovarian cancers.  It will also assess pharmacokinetics, biomarkers and initial evidence for efficacy.

SOR-C13 is a targeted peptide derived from the venom of the northern short-tailed shrew.  It works by inhibiting a “non-voltage gated calcium channel” found in epithelial cancers, such as ovarian, breast, prostate and others.  Earlier studies have shown that SOR-C13 induces apoptosis or, cell death, inhibits cell proliferation and reduces tumor volume, while minimizing side effects associated with typical chemotherapy.

“Unlike chemotherapy, Soricimed’s cancer treatment is highly targeted – affecting only cancer cells that over-produce this strange ion channel,” Jack Stewart, chairman and CSO, said in a statement.

“Healthy cells are not affected. It’s also derived from a naturally occurring peptide that, when broken down, produces amino acids that are normally used by the body. As a result, and this is key, there have been virtually no side effects demonstrated in our preclinical studies,” he added.

The Phase 1 trials will continue until the first quarter of 2014, with interim results expected later this year.  Based on successful results, further clinical trials will follow. Soricimed is hopeful that SOR-C13 could get to market in the next three-to-five years.

Dr. June Almenoff

Ohr Pharmaceutical (OTCQB: OHRP)has appointed Dr. June Almenoff to the board of directors.

In a statement, CEO Dr. Irach Taraporewala said Dr. Almenoff offers tremendous expertise in the areas of pharmaceutical research and development, risk management, and product licensing.

“We look forward to working with June as we continue to achieve significant corporate milestones, including the halfway point in enrollment of the Squalamine eye drop Phase 2 clinical trial and our proposed listing on NASDAQ, both expected by mid-year.”

Dr. Almenoff said ”Ohr has a promising pipeline and excellent team, and I look forward to working with the board to help drive the company toward future success.”

Dr. Almenoff is president and CMO of Furiex Pharmaceuticals (NASDAQ:FURX). She also serves as the company’s principal executive officer and a member of the board of directors.

Aradigm has completed Phase 2b clinical trials in BE patients with Pulmaquin and Lipoquin.

Under the accord, the companies have agreed to advance Aradigm’s proprietary inhaled ciprofloxacin formulations into Phase 3 clinical trials in BE, with Grifols responsible for all development and clinical expenses up to a maximum of $65-million for the BE indication.

Aradigm is entitled to receive up to $25-million on achievement of development milestones and is in line for tiered royalties on worldwide sales of products utilizing Aradigm’s proprietary inhaled ciprofloxacin formulations. Grifols also will be granted an option to license Aradigm’s AERx pulmonary drug delivery platform for use with another molecule.

Subject to approval of Aradigm’s shareholders, Grifols will acquire 35% of Aradigm’s common stock on a fully diluted basis at a price of 12.4 cents a share or about $26-million.

Existing Aradigm shareholders, including Tavistock Life Sciences and accounts managed by First Eagle Investment Management, and new investors, Great Point Partners, will co-invest in the transaction and purchase an additional $15.4-million in Aradigm common stock.

Closing is set for the second half of 2013, when Grifols will be entitled to designate two directors to the Aradigm board.

“Grifols is a great fit for us, with their global reach of respiratory physicians treating a number of conditions that could benefit from Pulmaquin,” Igor Gonda, president and CEO of Aradigm said in a statement.

Ramon Riera, president of Global Commercial for Grifols, said Pulmaquin will complement the company’s existing Prolastin-C business. “There is significant overlap between Bronchiectasis and Alpha1 physicians and patients. When launched, Grifols will leverage its existing pulmonary sales team to commercialize Pulmaquin,” he added.

Nadav Kidron

“We are very pleased to have the FDA clearance to proceed,” CEO Nadav Kidron said in a statement. “The upcoming trial is a major milestone for Oramed and we look forward to continuing to progress ORMD-0801′s clinical development in the U.S.”

ORMD-0801 is an orally ingestible insulin capsule indicated for the early stages of Type 2 diabetes, when it can still slow the rate of degeneration of the disease by providing additional insulin to the body and allowing pancreatic respite.

Orally administered insulin also has the potential benefit of enhanced patient compliance as well as the advantage of mimicking insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream.

The study, conducted at Indiana University, clearly indicates that the majority of patients treated by Medigus’ endoscopic system SRS were able to stop taking daily PPl (drugs that have a long-lasting reduction effect of gastric acid production) in the third year after the procedure.

The three-year study follows five-year results of a pilot study of the SRS endoscopic system for the treatment of gastroesophageal reflux disease (GERD). The pilot study had been conducted at the Deenanath Mangeshkar Hospital and Research Center in India in 2007.

According to lead investigator of the pilot study, Dr. Amol Bapaye, the five-year follow-up results are similar to those produced by a laparoscopic-surgical procedure for the treatment of GERD in the same timeframe.

“Medigus has developed an innovative solution to treat GERD and we’re excited to present the excellent supportive data from our three-year study and five-year follow-up,” CEO Dr. Elazar Sonnenschein said in a statement.

“It is rewarding to watch patients that no longer need to rely on daily use of drugs to support their routine,” Dr. Sonnenschein said. “We strongly believe that our minimal invasive solution will replace many of the unnecessary surgeries which are performed today.”

The complete SRS™ system including the console, the endoscope and standard monitors (not included)

The endoscopic system SRS performs a minimally-invasive treatment of GERD, one of the most common chronic diseases globally. The system, which includes a disposable surgical endoscope, performs an anterior fundoplication in lieu of the current surgical procedure, without incisions and opening the abdominal cavity.

The SRS offers a treatment by an independent device that doesn’t require any additional components during the procedure. The operation is rather intuitive and can be performed by one surgeon or GI.  In addition, the procedure can be conducted in the endoscopy suite to ensure the saving of operation room time.

“We are very optimistic about the [near-term] and [long-term] potential of the technology as the system is already both FDA-approved and CLIA-waived, allowing it to be placed directly into ophthalmology and optometry practices,” writes analyst Drew Jones.

He said TearLab’s Osmolarity system also does not face any immediate competition. “Taking into account the company’s commercialization strategy (focused on ophthalmologists) and what we believe is a conservative approach to sizing the market, we believe the market opportunity for TearLab is around $576-million today.”

Longer term, he expects TEAR to expand its sales effort to include optometrists that would “easily push the market opportunity for TearLab north of $1.4-billion.”

He said the stock’s valuation is “compelling despite a recent run up.”

This conference brings together brings together U.S., Canadian and international investors who are interested in the latest developments in the Canadian healthcare sector.

A few of us from BioTuesdays will also be attending.  If you would like to meet there with a particular Canadian company CEO that we interviewed this year, or you are a C-suite executive that would like to introduce your company’s story to us at BioTuesdays, please let us know.

The stock was changing hands at $9.03, up 13%, after touching a 52-week high of $9.16 on Tuesday morning.

Feltl analyst Ben Haynor upped his price target to $11 from $9.50, writing that he has increased his estimate for 2013 system orders to 1,263 from 1,120, citing the Master’s program placement. He said management noted on a conference call that they expect approximately half of their placements to be part of that program for the next couple of years.

Craig-Hallum analyst Steven Crowley raised his price target to $10 from $8.50, writing that TearLab is in the “midst of capturing a large and very lucrative market with an already FDA-approved, CLIA- waived, and CMS-reimbursed point-of-care test that is likely to become standard-of-care within an especially attractive medical specialty” for the quantitative diagnosis of dry eye disease.

“We think investors need to own this first mover with a novel point-of-care diagnostic platform play in the very attractive eye care market,” Mr. Crowley added.

Canaccord analyst Jeff Frelick also moved his target to $10 from $8, writing that he expects the “strong ramp to continue through 2013.”

“TearLab crushed our first quarter bookings estimate, driven by strong growth in its Master’s program with large ophthalmology practices,” writes Mr. Frelick.

TearLab booked 388 orders in the quarter for its osmolarity device, which is used to diagnose and manage dry eye disease, well ahead of Canaccord’s estimate of 234. TearLab also placed 324 instruments in the quarter, well ahead of Canaccord estimate of 114.

Roth analyst Matt Dolan raised his price target to $9 from $7.50, pointing out that the most important component to his thesis is the implied revenue that will be generated by each system in the field.

He said that on the conference call, management reiterated its belief that each TearLab system can generate $20,000 annually, implying that its current U.S. order base of 1,101 units would generate $22-million in annual card revenue.

“If the company’s quarterly order rate remains strong (as we saw in the first quarter), then we believe this revenue run rate could accelerate significantly over the next several quarters,” Mr. Dolan added.

Finally, Sidoti & Co. upgraded TearLab to “buy” from “neutral,” based on higher growth estimates for 2013 and 2014, and a roll out of 2015 profit estimates.

A total of 388 orders for TearLab Osmolarity systems were booked in the latest quarter. Of those, 162 systems were under the company’s new “Masters Multi Unit Program,” 195 were through its “3/15″ and “3/24″ access programs, 11 were direct purchases and 20 were purchased outside of the U.S.

“We started 2013 with strong system orders and a solid launch of our new Masters program,” CEO Elias Vamvakas said in a statement “While our revenue growth highlights our continuing success in building a recurring revenue base, like in previous quarters, our strong sales performance was not fully reflected in our first quarter financial results due to the traditional lag between access program contract signing and product shipment, and to our current system manufacturing back-order position.”

He said that moving forward, “driven by the success of our sales and marketing programs, and by strong showings at key events like ASCRS, we expect to see this positive momentum continue through the year.”