business plan july 2012 neolaser - ent july...
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Business Plan July 2012neoLaser - ENTJuly 2017
• Private company• Headquarters and R&D in Israel• Founded in 2012• 2013-2014, 2014-2015, 2015-2016 CAGR 50-60%• > 30 distribution partners globally in North America, Europe, Asia,
Pacific and South/Central America regions• Key areas of activity – EVLA, Colorectal, Spine, ENT• Laser manufacturing in dedicated GMP compliant facility in Israel• Fiber manufacturing in Germany
The Company
neoLaser designs and manufactures top quality laser devices for the medical field
• Founded and managed by Mr. Gil Shapira, engineer and physicist, MIT graduate, over 15 years of experience in developing, building and managing surgical lasers for multiple specialties. Previously VP Product Development and VP Marketing for OmniGuide, a Boston based MIT high growth surgical laser company
• Management team with over 50 years of combined specific domain experience in high end surgical lasers– Mrs. Dorit Rabkin, Quality and Regulatory Affairs, Lumenis
(Nasdaq LMNS), Yokneam Israel– Mrs. Galit Levite, Finance and Purchasing, Orsan, Israel– Mr. Gil Hadari, Manufacturing, OmniGuide, Boston MA
The Company - Leadership
… the company, cont.• GMP compliant manufacturing facilities
(Laser and Fibers)• ISO13485 quality system• CE certification for neoV platform and all
models• 2 FDA Clearances (K133006, K152722)
covering all indications• Partnership with Adler K152417 on fibers
neoV System Deployment Global
Current install rate of 150 systems per year globally
Key Markets: Germany, Netherlands, Italy, Australia, Spain, USA
• Precision
• Unique design
• Portability
• Quality
• Reliability
• Usability
• 810, 980, 1064, 1470
The neoV Laser
Tissue Interaction
Low absorption in Water and BloodAlmost equal absorptionVersatile tissue interaction (contact/non-contact)
Specifications25Watts clean out of fiberRed aiming beam1-25W in 0.1W stepsPulses from 100usec to 30secSingle or Repeat Pulse
Key Advantages
Unique designPortabilityStrong power outputUsabilityVersatile and powerful office-based tool
Products: neoV980
Overview
Otosclerosis, Septal deformation, polyps, cysts, tonsillectomy, DCR, pappiloma surgery, excision of cancerous lesions and many more are all ENT conditions/ procedures treated with Laser Microsurgery
Laser energy is used to vaporize, ablate and cut soft tissue with controlled lateral thermal injury capable of coagulating blood vessels.
The 980nm laser, with almost equal absorption by blood and water in tissue, provides a versatile tool for precision cutting and strong coagulation in one source.
Tissue Absorption
Lower absorption in waterNon-contact = deep penetrationContact = carbonization of tip and low penetration
980 Diode Cut 7W, Contact CO2 Laser Cut 7W
Otology - Otosclerosis
Otosclerosis is a fibrous osteodystrophy of the human otic capsule; abnormal bone growth in the inner ear causing hearing loss and possible damage to the hearing nerve.
Suggested causes include: Hereditary, infectious (Measles), traumatic. Most common in (but not limited to) Caucasian women in their 40s.
Otology - Stapedotomy
Stapedotomy
When surgical approach is preferred, laser provides the best solution enabling micro surgery with minimal acoustic and mechanical trauma. The 980nm wavelength also offers controlled thermal damage.
Otology - Treatment
The recommended settings provided in this manual are a general guide that does not replace the experience of the users, their knowledge of the procedure and what may be
required for each and every patient.
• For this delicate operation it is recommended to use a power of 2.5W-3W and pulse duration of 100-200ms at SP mode
• Stapedotomy is performed using a thin optical fiber (273µ core). In preparation for surgery “pre-blackening” (carbonization) of the fiber tip is required.
• ALWAYS – BLACK TIP + CONTACT
• 980nm is safe and effective for stapes surgery
• General behavior similar to KTP (green laser) when applied in the same way (contact mode)
Otology - Clinical Data
• 100 patient study at Causse Clinic with the neoV980 (Dr. Robert Vincent) completed
• Awaiting publication of long term follow up later this year
• Initial estimated success rate of 90% (in line with KTP)
• First tool of choice for Causse Clinic
Otology - Clinical Data Cont
• Turbinate surgery / reduction
• Nasal and paranasal sinus surgery
• HHT treatment
• Polyps, cysts, mucoceles
Rhinology – Endonasal Surgery
• Publications and white papers on turbinate reduction and HHT
• Advantages
– Precision surgery
– Control of bleeding
– Short recovery
– Visualization
– Possible surgery under local anesthesia (also in office)
Rhinology – Clinical Data
• ~15W, CW
• Horizontal lines (from anterior section of turbinate to posterior section)
• 3-4 lines per turbinate
• Total of ~100Joules per turbinate
• No nasal packing needed
• Antibiotic ointment after application
• Patients should do saline wash 3 times a day for 3 weeks
Turbinate Surgery - Technique
• HHT– Non contact application
– 12-16W, blanch lesion until coagulated
– Tolerated as in office procedure
– Can be easily repeated if needed
• Polyps– 16W, CW
– If very small polyp can be ablated in non contact mode
– If bigger, cut at base in contact mode
HHT and Polyps
• Laser tonsillotomy in children (LTT)
• Laser-assisted Uvulopalatoplasty (LAUP) for snoring prevention
• Tumor resections
• Partial glossectomy
Oropharynx - Procedures
• Use of Diode lasers in laryngeal surgery
– Granulomas, polyps, web, papilloma
– Glottic carcinoma
– Subglottic stenosis, lesions
Laryngeal Procedures
• 980nm is a wavelength which may penetrate the eye and cause irreversible damage (due to lower water absorption)
• Just like KTP (green) it is more dangerous than CO2
• Requires safety goggles and special filter on the microscope
Safety Considerations
Products
Product Code Description Comments
OF99003 CORONA OTO fiber, 2.6meters length, 273um core, Slim, polyimide coating, OD 330um, Sterile
Slim fiber for otology. Compatible with surgical hand piece
OF99005 CORONA ENT fiber, 2.6meters length, 360um core, Slim, polyimide coating, OD 420um, Sterile
Slim fiber for general ENT use. Compatible with surgical hand piece
HS99001 ENT hand pieceResterilizableFor CORONA OTO and ENT fibers
Luer lock ending, compatible with all size/shape cannulas
ZUXXXXX Stainless steel extension cannulas, Various lengths and shapes
Compatible with surgical hand piece
BG03017 Eye protection filter, Zeiss/Moeller800-1100nm, Permanent, clear view
Effective eye protection for surgical microscope
BG03018 Eye protection filter, Leica800-1100nm, Permanent, clear view
Effective eye protection for surgical microscope
Thank you
neoLaser7 HaEshel St.
Caesarea Industrial ParkISRAEL 38900